TUBING, SUCTION, CONNECTOR, 3/16" X 12' (5 MM X 3.7 M)
Received Feb 6, 2025 · Event occurred Jan 7, 2025
Report 1060680-2025-00014 · MDR key 21327164
Device
Generic name
Tube, Aspirating, Flexible, Connecting
Manufacturer
Arrow Medsource Group LimitedModel number
71-C512Product problems
- Failure to Seal
- Failure to Seal
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED THAT THE 5MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY. DEROYAL INDUSTRIES REVIEWED THE SAMPLES RETURNED FROM THE CUSTOMER AS WELL AS SEPARATE LOTS PULLED FROM THE DISTRIBUTION CENTER. 15 CASES OF TUBING WERE CHECKED AND 4 DEFECTS WERE FOUND. NO FAILURE MODES AND EFFECTS ANALYSIS COULD BE REVIEWED BY DEROYAL AS THIS IS A PURCHASED PRODUCT. DEROYAL DID REVIEW ENGINEERING CHANGE ORDERS RELATED TO THIS PRODUCT, BUT NO ISSUES WERE FOUND. DEROYAL RAN A COMPLAINT TO SALES RATIO FOR THIS PRODUCT FROM NOVEMBER 2022 TO NOVEMBER 2024 AND FOUND IT TO BE (B)(4). THE SCAR WAS RETURNED AFTER THE SUPPLIER COMPLETED THEIR INVESTIGATION. THE SUPPLIER PULLED THEIR EXISTING INVENTORY AND RANDOMLY SAMPLED 472 EACHES OF TUBING. FOUR PRODUCTS WERE FOUND TO BE TOO DEEP. ROOT CAUSE: THE SUPPLIER DETERMINED THE ROOT CAUSE TO BE A MANUFACTURING/ QUALITY CONTROL ISSUE. THE ASSEMBLY STAFF WERE FOUND TO HAVE IMPROPER FORCE CONTROL DURING INSTALLATION WHICH RESULTED IN AN INCONSISTENT DEPTH. CORRECTIVE AND PREVENTIVE ACTIONS: THE SUPPLIER TOOK SEVERAL CORRECTIVE AND PREVENTIVE ACTIONS DUE TO THIS ROOT CAUSE. THE CONNECTOR LIMIT LINE WAS INCREASED FROM 0.15MM TO 0.75MM. THE WORK INSTRUCTION BOOK WAS ALSO UPDATED TO CHANGE THE FEED AND PROCESS INSPECTION INSTRUCTIONS AND ADD THE MEASUREMENT OF THE JOINT STOP LINE AND JOINT DEPTH. THIS CHANGE IN THE PROCESS WAS THEN RETRAINED FOR APPLICABLE STAFF TO ENSURE COMPLIANCE TO THE NEW JOINT ASSEMBLY CHANGES. THESE CORRECTIONS WERE THEN CONFIRMED TO BE EFFECTIVE THROUGH THEIR PROCESS QUALIFICATION SHOWING THE NEW DEPTH OF THE PIPE WAS EFFECTIVE. DEROYAL INDUSTRIES INITIATED A RECALL TO REMOVE PRODUCTS FROM THE FIELD THAT WERE MANUFACTURED PRIOR TO THE CORRECTIONS MADE BY THE SUPPLIER/MANUFACTURER. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A USER FACILITY REPORTED THAT THE 5MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY. DEROYAL INDUSTRIES REQUESTED THE RETURN OF THE DEVICE BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE 5MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY.
Remedial action
- Recall