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

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was "on saturday (b)(6) 2022 nurse and i were placing a picc line.Picc line insertion had no complication or resistance, and it was a quick and smooth procedure.After every picc line insertion we always do a double verification to make sure we have all the materials from the kit and that all wires are intact.However, the stylet wire (which is the wire that is inside the picc line catheter) was bent.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy1272 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was "on saturday (b)(6)2022 nurse and i were placing a picc line.Picc line insertion had no complication or resistance, and it was a quick and smooth procedure.After every picc line insertion we always do a double verification to make sure we have all the materials from the kit and that all wires are intact.However, the stylet wire (which is the wire that is inside the picc line catheter) was bent.".
Additional Manufacturer Narrative
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: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent wire was confirmed, but the exact cause was unknown.Three photographs were provided, two of which depicted a 3cg stylet wire.The third photograph contained product information.In the two images which depicted the 3cg stylet tip, a single kink was seen within the distal 1/3 region of the magnet tip.No observable evidence suggested the cause of this event.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.This event will be recorded for future trending and monitoring of this complaint type.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY
• 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: 14316218
• Report Number: 3006260740-2022-01658
• Device Sequence Number: 17351961
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/25/2022

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: S1395108D
• Device Lot Number: REFY1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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