MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL; 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 Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2019
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 recz1365 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during picc dressing change, nurse flushed white lumen with saline and noticed the dressing was saturated.A hole was noticed close to the hub and the line was dc'd immediately.
Event or Problem Description
It was reported that during picc dressing change, nurse flushed white lumen with saline and noticed the dressing was saturated.A hole was noticed close to the hub and the line was dc'd immediately.
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 leak is confirmed; however, the exact cause is unknown.One 5 fr triple lumen powerpicc was returned for evaluation.An initial visual observation showed use residue on the returned sample.The 0 cm to 7 cm depth markers were observed to be worn and faded.Each lumen of the catheter was flushed with a 12 ml syringe of water and a spraying leak was found in the white lumen, just distal to the molded joint.A microscopic observation revealed a short, longitudinal split in the catheter at the leak site.The edges of the split were observed to be mostly straight and with a smooth and granular surface texture.Evidence of kinking was observed on the surface of the catheter opposite the location of the split.The catheter was dissected in order to observe the inner wall of the catheter lumen.The split was observed to be slightly shorted when viewed from the interior of the catheter, suggesting the damage likely originated form the outer wall of the catheter.Also, the edges of the split were observed to be slightly rougher on the interior side of the split.While the exact cause of the split is unknown, possible contributing factors include prolonged and/or repetitive kinking of the catheter and instrument damage.A lot history review (lhr) of recz1365 showed one other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET FULL
• 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: 8917680
• Report Number: 3006260740-2019-02438
• Device Sequence Number: 16711165
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 1385108Q
• Device Lot Number: RECZ1365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1