MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 5F DL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeu0295 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "when flushing picc line to prepare for insertion, noted hole in extension tubing - fluid leaked from hole when flushing picc catheter.Hole was in extension tubing connected to red port and was on the side with the wire for the 3cg and sherlock.Found before picc was inserted into patient so no harm to patient.Obtained new picc for insertion into patient".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole in the extension tubing was confirmed.One 5 fr dl powerpicc catheter was returned for evalatuion.The 3cg stylet t-lock assembly was returned within the catheter.The catheter has not been trimmed.No apparent evidence of use was observed on the catheter tubing.Two kinks in the the t-lock extension leg were present.A split in the extension leg was present 2 cm from the t-lock hub.The split was microscopically inspected.Striations were observed on the break surface which was observed to be mostly flat.Additional superficial circumferential splitting was noted at the corners of the split.The damage was consistent with damage caused by a bladed instrument such as scissors.Since the split was found on the extension tubing and appeared to have occurred during handling of the device, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "when flushing picc line to prepare for insertion, noted hole in extension tubing - fluid leaked from hole when flushing picc catheter.Hole was in extension tubing connected to red port and was on the side with the wire for the 3cg and sherlock.Found before picc was inserted into patient so no harm to patient.Obtained new picc for insertion into patient.".

• Brand Name: POWERPICC CATHETER 5F DL 3CG
• 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: 10765859
• Report Number: 3006260740-2020-20330
• Device Sequence Number: 17093404
• Product Code: LJS
• UDI-Device Identifier: 00801741184253
• UDI-Public: (01)00801741184253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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,Followup
• Report Date (Section B): 12/01/2020

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 Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000871A
• Device Lot Number: REEU0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/25/2021
• 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