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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
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) of refx1761 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "stylet wire was bent/kinked coming out of the package." no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx1761 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "stylet wire was bent/kinked coming out of the package." no other information was provided.
Event or Problem Description
It was reported "stylet wire was bent/kinked coming out of the package." no other information was provided.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint of a kinked stylet was confirmed.One 5fr triple-lumen powerpicc solo was returned for investigation.The catheter was received with the 3cg stylet in the lumen.The catheter tubing had been trimmed at the 38cm depth mark and the stylet extended 8.8 cm beyond the trimmed end of the catheter.The polyimide tubing and core wire were kinked 5.9cm and 2.9cm from the distal tip of the 3cg stylet.The exposed stylet may have been a contributing factor in the reported complaint.Advancing the stylet against resistance can also cause the wire to bend; however, there were no distinguishing features which could aid in identification of a specific root cause.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13596104
• Report Number: 3006260740-2022-00450
• Device Sequence Number: 13942388
• Product Code: LJS
• UDI-Device Identifier: 00801741155123
• UDI-Public: (01)00801741155123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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 Model Number: N/A
• Device Catalogue Number: S1395108D4
• Device Lot Number: REFX1761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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