ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVIC
Received Nov 26, 2013 · Event occurred Oct 30, 2013
Report 2243969-2013-00248 · MDR key 3659412
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Convatec Inc.Model number
ABV321Catalog number
ABV321
Lot number
UNK
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
EMAIL REC'D FROM SUPPLY CHAIN DIRECTOR INDICATES THAT THE SYRINGE TIP HAD BROKEN OFF IN THE VALVE STEM AND OCCLUDED WHILE IN THE PACKAGE.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THIS INFO WAS FORWARDED TO (B)(4) AT (B)(4) AND AN EMAIL WAS SENT TO (B)(4), SUPPLY CHAIN DIRECTOR, REQUESTING PRODUCT LOT NUMBER. NO RETURN EMAIL RESPONSE REC'D TO DATE, AND AN INVESTIGATION REQUEST WAS SENT TO MFR ON (B)(4) 2013. LASTLY, THERE WAS NO REPORT OF A PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.