MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO VALVE TECHNOLOGY 5F TL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refp4380 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "we were placing a triple lumen picc last week and noticed leaking around the hub/catheter right after inserting the picc into the patient.We have the sample that we can send in.The lot number is refp4380." additional info rcvd 07/20/2021 "rn placing line and noted saline bubbles at the distal hub tip while attempting to flush while inserting line.Leaking noted and picc removed and new line placed.".
Event or Problem Description
It was reported "we were placing a triple lumen picc last week and noticed leaking around the hub/catheter right after inserting the picc into the patient.We have the sample that we can send in.The lot number is refp4380." additional info rcvd (b)(6) 2021 "rn placing line and noted saline bubbles at the distal hub tip while attempting to flush while inserting line.Leaking noted and picc removed and new line placed.".
Additional Manufacturer Narrative
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 triple lumen powerpicc provena solo catheter was returned for evaluation.A microscopic observation revealed a circumferential split across both lumens in the catheter tubing just distal to the molded joint.The edges of the split were observed to be mostly straight and even with some whitening of the catheter material at the corners.One corner of the split was observed to be slightly curved.Striations were observed on the fracture surfaces of the split, which were found to be flat and granular in texture.While the exact cause of the damage observed in the returned catheter could not be determined, possible causes include sharp instrument damage, material fatigue, and damage during handling or use.

• Brand Name: POWERPICC PROVENA SOLO VALVE TECHNOLOGY 5F TL 3CG
• 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: 12278535
• Report Number: 3006260740-2021-03152
• Device Sequence Number: 4599419
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 09/16/2021

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: S1395108D
• Device Catalogue Number: S1395108D
• Device Lot Number: REFP4380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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