MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV 3F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1173118
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rees1289 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "stylet has concerning kink that looks like it could have easily fractured inside patient.There was minimal resistance advancing or retracting catheter during procedure.Nothing about the procedure makes nurse believe it may have caused such a severe kink in stylet." additional information provided 2/9/2021: it was reported kink found after placement.Minimal resistance advancing or retracting catheter during procedure.
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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked stylet is confirmed but the exact cause remains unknown.One 3cg stylet was returned for evaluation.The white cable was returned cut.A sharp 90-degree bend was present 5.3 cm from the distal end.An additional slight bend was noted 5.8 cm from the distal end.Microscopic observation of the kink location and distal end revealed the stylet to be intact.The sharp kink was located in between two magnets within the polyimide tubing.The polyimide tubing was cut near the damaged region in order to measure the wall thickness.The wall thickness was found to be within manufacturing specification.Based on the condition of the returned sample, possible contributing factors include damage during handling, damage during insertion, and advancement against resistance.Since a kink in the stylet tubing was observed, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via medwatch "stylet has concerning kink that looks like it could have easily fractured inside patient.There was minimal resistance advancing or retracting catheter during procedure.Nothing about the procedure makes nurse believe it may have caused such a severe kink in stylet." additional information provided 2/9/2021: it was reported kink found after placement.Minimal resistance advancing or retracting catheter during procedure.

• Brand Name: POWERPICC SV 3F SL 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: 11340833
• Report Number: 3006260740-2021-00367
• Device Sequence Number: 2384855
• Product Code: LJS
• UDI-Device Identifier: 00801741086892
• UDI-Public: (01)00801741086892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 1173118
• Device Catalogue Number: 1173118
• Device Lot Number: REES1289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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