MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
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 redw0438 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the product was inserted (b)(6) 2020 with a confirmed placement.On (b)(6) the patient returned to emergency department noting that the picc line had been leaking.It was further reported that the picc line was removed and a slit with a length of 1 cm was noted.
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 3fr s/l powerpicc sv catheter.Usage residues were observed throughout the sample.Curved shape memory was observed throughout much of the catheter shaft.A longitudinally aligned split was observed between the 5cm and 6cm depth markings.An attempt to infuse water through the sample using a 12ml syringe revealed a spraying leak at the split site.The sample was completely occluded distal of the split.Microscopic inspection of the split revealed a granular fracture surface.Discoloration and thinning of the catheter wall were observed in the vicinity of the split.The fracture features were consistent with burst damage secondary to over-pressurization.The occlusion distal of the split suggested that flushing against resistance likely contributed.The product ifu states ¿warning: failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ the ifu also provides guidance regarding suggested catheter maintenance and clearance of blood product occlusions.
Event or Problem Description
It was reported that the product was inserted (b)(6) 2020 with a confirmed placement.On (b)(6) 2020, the patient returned to ed noting that the picc line had been leaking.It was further reported that the picc line was removed and a slit with a length of 1 cm was noted.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS
• 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: 10681176
• Report Number: 3006260740-2020-20125
• Device Sequence Number: 4123101
• Product Code: LJS
• UDI-Device Identifier: 00801741086892
• UDI-Public: (01)00801741086892
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 1173118
• Device Lot Number: REDW0438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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