MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3CG 4F FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of wet packaging was confirmed and likely occurred during transit/storage.Five 4fr s/l powerpicc catheter kits were returned for evaluation.All five kits were unopened.No liquid was seen on the outside or inside of the packaging.No water stains were seen on the labels or packaging lidstock.However, ink transfer from the red label on the outer component pouch was seen on all five pouches.This may indicate that the pouches had become wet at some point.The saline syringes in the outer pouch of the kits were confirmed to contain the end caps and were filled with 10ml of fluid.The kits were opened by the investigator and the chloraprep applicators and lidocaine vials were examined.The internal vial on the chloraprep applicators were intact and contained liquid.All lidocaine vials were undamaged and had not been opened.Although the kits were not wet when returned for evaluation, the ink transfer indicated that liquid was likely present on the kits at one point in time.As no damage was seen to the kit components that contain fluid, the liquid was likely from an external source.Possible contributing factors could include environmental sources such as high humidity or precipitation.A review of the manufacturing records showed no evidence that the reported event was associated with the packaging or labeling process.A lot history review (lhr) of reex1081 showed four similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that the packaging of five picc kits were wet.This report addresses the first kit.

• Brand Name: POWERPICC 3CG 4F FULL TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12291172
• Report Number: 3006260740-2021-03189
• Device Sequence Number: 3181412
• Product Code: LJS
• UDI-Device Identifier: 00801741034442
• UDI-Public: (01)00801741034442
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1174108
• Device Lot Number: REEX1081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other