MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 3F SL STIFFING STYLET 65CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4133105
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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; however, the root cause was not identified.The product returned for evaluation was one segment of digital video which depicted a 3fr s/l per-q-cath catheter.The depicted device was implanted in a patient.Approximately 7cm of catheter shaft and the molded joint/luer adapter were visible.The t-lock assembly was attached to the luer adapter.A syringe was attached to the luer adapter.The catheter was being flushed and a spraying leak was visible at the luer/suture wing joint.While leakage was evident in the submitted video, inspection of the video was insufficient to identify the cause of the leak.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include stylet damage and contact with a sharp instrument.A lot history review (lhr) of redv2093 showed four other similar product complaint(s) from this lot number.
Event or Problem Description
Customer reports a leakage in catheter/hub connection.No other information was provided.

• Brand Name: PER-Q-CATH PLUS 3F SL STIFFING STYLET 65CM
• 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: 12218035
• Report Number: 3006260740-2021-02944
• Device Sequence Number: 16491382
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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: 07/31/2022
• Device Model Number: 4133105
• Device Catalogue Number: 4133105
• Device Lot Number: REDV2093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: 4 YR