MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO® CATHETER 5F DL FT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "picc placed with no resistance or issues, picc placer.Once picc was placed in proper caj the stylet was removed.It was noted the that end of the stylet was bent and looked like it was going to fall off.Placer placed the stylet on the tray and the end of the stylet fell off.The picc team verbalized concern for stylet breaking off in patient.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq1521 showed no other similar product complaint(s) from this lot number.
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, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the 3cg stylet was confirmed but the cause is unknown.Two photographs of a 3cg stylet inside a biohazard bag were returned for evaluation.Usage residue was seen on the stylet indicating that the wire had been used.A small, detached segment of the stylet was found in the lower corner of the bag.The segment consisted of the magnetic region of the wire and contained the distal tip.The detached segment appeared to retain a curved shape memory which may indicate a tortuous path during picc insertion.Possible contributing factors for the break include complications during catheter placement; however, it was reported that the picc was placed without resistance or issues.Another potential contributing factor includes extending the stylet past the end of the catheter.The ifu warns, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and/or risk of patient injury.¿ it is unknown if additional unknown factors contributed to this event.Although the break in the wire could be confirmed, the root cause could not be determined from the returned photos.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "picc placed with no resistance or issues, picc placer.Once picc was placed in proper caj the stylet was removed.It was noted the that end of the stylet was bent and looked like it was going to fall off.Placer placed the stylet on the tray and the end of the stylet fell off.The picc team verbalized concern for stylet breaking off in patient.".

• Brand Name: POWERPICC SOLO® CATHETER 5F DL FT 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
• 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: 13018720
• Report Number: 3006260740-2021-05336
• Device Sequence Number: 4911907
• Product Code: LJS
• UDI-Device Identifier: 00801741188107
• UDI-Public: (01)00801741188107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 01/25/2022

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: CK000931
• Device Lot Number: REFQ1521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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