UNSPECIFIED BD INSYTE CATHETER
Received Mar 1, 2022 · Event occurred Feb 10, 2022
Report 2243072-2022-00298 · MDR key 13640337
Device
Generic name
Intravascular Catheter
Manufacturer
Becton DickinsonCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
11 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNSPECIFIED BD INSYTE CATHETER SPLIT DURING PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "RUPTURE OF VENOUS CATHETER. WHEN PERFORMING A PUNCTURE, A SOFT (PLASTIC) CATHETER IS OBSERVED TO BREAK INTO 2 PARTS, WHICH IS WHY IT IS NOT POSSIBLE TO CHANNEL THE VEIN USING CATHETER."
Additional Manufacturer Narrative
DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT THE UNSPECIFIED BD INSYTE CATHETER SPLIT DURING PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "RUPTURE OF VENOUS CATHETER. WHEN PERFORMING A PUNCTURE, A SOFT (PLASTIC) CATHETER IS OBSERVED TO BREAK INTO 2 PARTS, WHICH IS WHY IT IS NOT POSSIBLE TO CHANNEL THE VEIN USING CATHETER."
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.