MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen1256 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "pulled out according to protocol without resistance, during the course it was pulled out 38 cm as inserted, but it was noticed that the tip was broken.".
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 damaged catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs depicting a 4fr s/l powerpicc catheter.Marking wear was evident in the photographs.A partially circumferential split was observed near the distal tip of the catheter.The split progressed nearly entirely through the catheter shaft.Damage was evident in the submitted photograph; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include sharp instrument contact and material fatigue.
Event or Problem Description
It was reported "pulled out according to protocol without resistance, during the course it was pulled out 38 cm as inserted, but it was noticed that the tip was broken." additional information received: bleomycin was infusing the day prior to the leak being discovered.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15054236
• Report Number: 3006260740-2022-02767
• Device Sequence Number: 4773263
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 3174155
• Device Lot Number: REEN1256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown