MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM; 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that staff had problems infusing a 4fr dl picc and when it was removed it looked like it had a blow out.Add info rcvd: 07/20/2021: date of occurrence: about june 7th.Placement info: line was malfunctioning.On removal it looked like the catheter had a sidewall blow out.No info on placement.
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 damaged catheter is confirmed.One 4 fr dual lumen powerpicc sv catheter was returned for evaluation.An initial visual observation showed use residue on and within the returned sample.A large longitudinal split was observed in the catheter tubing between the 25 and 26 cm depth markers.Tensile weakness was observed in the catheter tubing around the area of the split.A microscopic observation revealed an additional circumferential split just distal to the large longitudinal split, and a small hole was found in the septum of the catheter tubing between these two splits.The edges of the longitudinal split were observed to be straight but somewhat rippled and the fracture surfaces were found to be flat and granular in texture.The edges of the circumferential split were observed to be straight with some superficial splitting, webbing, and whitening of the catheter material at the corners of the split.The fracture surfaces of the circumferential split were observed to be flat and granular.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.
Event or Problem Description
It was reported that staff had problems infusing a 4fr dl picc and when it was removed it looked like it had a blow out.Add info rcvd: 07/20/2021: date of occurrence: about (b)(6).Placement info: line was malfunctioning.On removal it looked like the catheter had a sidewall blow out.No info on placement.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM
• 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: 12276759
• Report Number: 3006260740-2021-03121
• Device Sequence Number: 14163205
• Product Code: LJS
• UDI-Device Identifier: 00801741035678
• UDI-Public: (01)00801741035678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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 Model Number: N/A
• Device Catalogue Number: 9274108D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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