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	04/26/2020
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 redp1359 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp1359) have been reported from the same facility.
Event or Problem Description
It was reported "picc have split at the hub of the lumen causing the fluid pathway to open and allow air and leakage." catheter was inserted on (b)(6) 2020 and it had broken by (b)(6) 2020.
Event or Problem Description
It was reported "picc have split at the hub of the lumen causing the fluid pathway to open and allow air and leakage." catheter was inserted on (b)(6) 2020 and it had broken by (b)(6) 2020.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a split in the catheter tubing was confirmed but the cause is unknown.The product returned for evaluation was a proximal segment of a 3fr s/l powerpicc sv catheter.The catheter had been cut between the 6cm and 7cm depth marking and the distal segment of the catheter shaft tubing was not returned for evaluation.The printing on the extension leg was worn.When an attempt was made to flush the catheter with water from a syringe, the catheter was patent to infusion.However, a spraying leak was seen emanating from the tubing, just distal of the luer adaptor.Microscopic examination of the leak site revealed a circumferential split near the distal end of the luer adaptor.The split in the tubing traversed approximately half of the circumference of the tubing.The split site was granular with irregular striations.A tubing fragment was seen proximal of the split site, inside the luer adaptor.This indicates that the tubing split rather than dislodged from the luer adaptor.A circumferential impression was noticed in the extension leg tubing 0.0688¿ distal of the luer.The extension leg was cut by the investigator near the center of the extension leg and the id, od and wall thickness were measured.The measurements were verified to meet the device specifications.The complaint of a leak in the catheter was confirmed.Based on evaluation of the returned sample, possible contributing factors could include torque forces applied near the luer joint, material fatigue, or tensile (pulling) forces.However, the exact cause of the split in the tubing could not be determined at this time.H3 other text : evaluation findings are in section h.11.

• 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: 10759206
• Report Number: 3006260740-2020-20286
• Device Sequence Number: 3525614
• Product Code: LJS
• UDI-Device Identifier: 00801741087103
• UDI-Public: (01)00801741087103
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/01/2020

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 Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1173108D
• Device Lot Number: REDP1359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/26/2021
• 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