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

Model Number	CK000670
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeu2694 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient known to pull lines out, nurse entered room and less than 3 cms of picc catheter was left under dressing.Catheter was not in patients arm but under the dressing and when nurse flushed, saline "shot out of the top of dressing." it is unknown where remainder of catheter is.Patient was sent to hospital and all scans were inconclusive.A new picc was placed without incident.Additional information received 11/25/2020: placement info: right brachial vein at 37 cms internal.
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 break is confirmed; however, the exact cause is unknown.One 4 fr single lumen powerpicc catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The catheter appeared to have been broken approximately 3.5 cm distal to the molded joint and the catheter was observed to be partially pinched or flattened at its distal tip.The 3 cm depth marker of the catheter near the break site was observed to be faded.A microscopic observation revealed the break site of the catheter was mostly flat and granular on one side and rough and uneven on the other side, which appeared to be pinched into a point.The catheter appeared to be bonded to itself on the side of the break that appeared to be pinched.What appeared to be some abrasive damage was observed on one side of the surface of the catheter leading up to the break site.While the exact cause of the break in the returned catheter could not be determined, possible causes include prolonged and/or repeated circumferential compression and mechanical damage caused by contact with a hard surface or instrument.H3 other text: evaluation findings are in section h.11.
Event or Problem Description
It was reported patient known to pull lines out, nurse entered room and less than 3 cms of picc catheter was left under dressing.Catheter was not in patients arm but under the dressing and when nurse flushed, saline "shot out of the top of dressing." it is unknown where remainder of catheter is.Patient was sent to hospital and all scans were inconclusive.A new picc was placed without incident.Additional information received 11/25/2020: placement info: right brachial vein at 37 cms internal.

• Brand Name: POWERPICC TPS 4F SL
• 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: 10993369
• Report Number: 3006260740-2020-20878
• Device Sequence Number: 4242146
• Product Code: LJS
• UDI-Device Identifier: 00801741130861
• UDI-Public: (01)00801741130861
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: CK000670
• Device Catalogue Number: CK000670
• Device Lot Number: REEU2694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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: 81 YR