MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 redv2851 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported rue picc placed in right brachial (b)(6) 2019.Pat presented today for picc exchange.She reported episodic pain just above insertion site reporting only with rapid infusions and fast flushes of saline.Patient stated this started around the first week of march.Patient presented with a very clean healthy appearing line and no symptoms of a dvt.Patient states a few weeks ago her arm swelled up and she noticed leaking at the insertion site during a rapid hydration treatment that resolved in a couple days.Picc removed and found to have a very small hole around the 3cm mark.Line was placed at 43cm 0 external length.Mac at time of insertion was 41cm and still 41cm today brachial vein was aprox 2.5 cm deep.After removal it was noted the line was trying to kink around the same mark where the damage was visualized.
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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hole is confirmed and was determined to be use related.One 5 fr triple lumen powerpicc provena catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.Kinks were observed in the returned catheter near the 3 cm and 4 cm depth markers.The ink on the molded joint, the extension legs, and the 0-3 cm depth markers was observed to be worn and faded.A microscopic observation revealed two circumferential splits in the catheter at the locations of the observed kinks.The edges of the splits were observed to be rough but mostly straight.The fracture surfaces of the splits were found to have an uneven and granular texture.Whitening of the catheter material was observed at the corners and edges of the splits, and additional longitudinal splits were observed near one corner of each of the circumferential splits.The surface of the catheter material was observed to be slightly less lustrous leading up to the edges of both splits.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The product ifu states: ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ a lot history review (lhr) of redv2851 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported rue picc placed in right brachial (b)(6) 2019.Pat presented today for picc exchange.She reported episodic pain just above insertion site reporting only with rapid infusions and fast flushes of saline.Patient stated this started around the first week of march.Patient presented with a very clean healthy appearing line and no symptoms of a dvt.Patient states a few weeks ago her arm swelled up and she noticed leaking at the insertion site during a rapid hydration treatment that resolved in a couple days.Picc removed and found to have a very small hole around the 3cm mark.Line was placed at 43cm 0 external length.Mac at time of insertion was 41cm and still 41cm today brachial vein was aprox 2.5 cm deep.After removal it was noted the line was trying to kink around the same mark where the damage was visualized.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F M
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9960741
• Report Number: 3006260740-2020-01303
• Device Sequence Number: 2808234
• Product Code: LJS
• UDI-Device Identifier: 00801741128387
• UDI-Public: (01)00801741128387
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1385108QD
• Device Lot Number: REDV2851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 108