MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (5F) (D; 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 will evaluate.Results are expected soon.A lot history review (lhr) of redu1435 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc began to leak from the hub connection the purple lumen at the connection to the tubing that houses the clamp on dwell day 9 and required replacement.
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 dual lumen powerpicc was returned for evaluation.An initial visual observation showed use residue on the returned sample.Both pinch clamps were observed to be engaged and needleless injection caps were returned on each lumen.The catheter appeared to have been trimmed approximately 2.6 cm distal to the bifurcation.A split was observed in the extension leg tubing of the purple lumen, just within the distal end of the luer hub.A microscopic observation revealed the fracture surfaces of the split were rough and exhibited cracks/fissures and beach marks, which are suggestive of material fatigue.Additional tearing was observed in the extension leg tubing of the purple lumen opposite the split, and the characteristics of the fracture surfaces of this tear were similar to the fracture surfaces of the split.While the exact cause of the split observed in the extension tubing of the returned sample is unknown, possible contributing factors include pulling, twisting, and manipulating the luer connector hub and/or extension leg.A lot history review (lhr) of redu1435 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc began to leak from the hub connection the purple lumen at the connection to the tubing that houses the clamp on dwell day 9 and required replacement.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (5F) (D
• 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: 9541211
• Report Number: 3006260740-2019-04041
• Device Sequence Number: 11369243
• Product Code: LJS
• UDI-Device Identifier: 00801741152573
• UDI-Public: (01)00801741152573
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: N/A
• Device Catalogue Number: CK000820
• Device Lot Number: REDU1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1