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

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reet1379 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "when flushing picc, a hole was discovered." no other information was provided.
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 review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole in the catheter is confirmed but the exact cause remains unknown.One 5 fr dl powerpicc catheter was returned for evaluation.The catheter was trimmed at the 17 cm depth marker.Blood residue was present on the catheter surface and hub.Material damage was noted near the proximal end of the catheter at the interface with the winged hub.Microscopic observation of the damaged section revealed three holes in the circumferentially aligned at the proximal catheter region.Two of the holes were separated by a section of the catheter which appeared to be pinched within the distal end of the molded hub.The third hold appeared to be a short, longitudinal split.The exact cause of the damage is unknown.Based on the condition of the returned sample, possible contributing factors include instrument damage or damage during handling.Damage during the manufacturing process may be a potential contributor to the observed catheter damage; however, no findings from the dhr review indicated a manufacturing/processing related event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "when flushing picc, a hole was discovered." no other information was provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F
• 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: 10822564
• Report Number: 3006260740-2020-20448
• Device Sequence Number: 3315805
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• 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): 12/30/2020

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 9275108D
• Device Lot Number: REET1379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 76