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

Model Number	9274108
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rees1337 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that wetness was observed (b)(6) 2020 with no evidence of leaking during dressing change.It was stated it was "damp" from (b)(6) 2020 to (b)(6) 2020 when nurses determined it was "wet" enough for a dressing change at which time the nurses observed the tpn/lipids leaking from the red lumen.No patient harm was reported.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 4fr d/l powerpicc sv catheter.Usage residues were observed throughout the sample and a statlock stabilization device was attached to the suture wings.Kink impressions and deformations were observed near the molded joint.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; however, when flushing the red-luered lumen, a leak was observed just distal of the molded joint.Microscopic inspection of the leak site revealed a longitudinally aligned split.The split occurred within a longitudinally aligned impression.Additional longitudinally aligned impressions were observed in the vicinity of the split.Kink impressions, deformation and discoloration were observed in the vicinity of the split.The split exhibited a granular fracture surface.The damage was consistent with kinking and compression damage leading to fracture formation and propagation in the catheter material.The location of the damage suggested that catheter securement, access and maintenance techniques likely contributed.
Event or Problem Description
It was reported that wetness was observed (b)(6) 2020 with no evidence of leaking during dressing change.It was stated it was "damp" from (b)(6) 2020 when nurses determined it was "wet" enough for a dressing change at which time the nurses observed the tpn/lipids leaking from the red lumen.No patient harm was reported.

• Brand Name: POWERPICC SV TLS 4F DL
• 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: 10993250
• Report Number: 3006260740-2020-20862
• Device Sequence Number: 14551980
• Product Code: LJS
• UDI-Device Identifier: 00801741028625
• UDI-Public: (01)00801741028625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 01/26/2021

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 Expiration Date: 10/31/2021
• Device Model Number: 9274108
• Device Catalogue Number: 9274108
• Device Lot Number: REES1337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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: 12 YR
• Patient Weight: 103