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

Model Number	S1395108D3
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that on the morning of (b)(6) 2020 when using a powerpicc provena on a patient, one of the valves detached from the picc.There was no patient harm and the device was not connected to any fluids.Additional information received 11/4/2020: device was placed (b)(6) 2020 and removed (b)(6) 2020.
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 lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the hub extension tubing is confirmed but the exact cause remain unknown.One 5 fr tl powerpicc solo catheter was returned for evaluation.The red hub was returned completely detached from the power injectable extension tubing.Blood residue was visible within the extension tubing.The catheter 55 cm depth marker and has not been trimmed.Microscopic observation of the distal end of the solo hub revealed a complete break in the extension tubing.The break edges were rough and uneven.The break surface was observed to have a granular texture.A section of the catheter break site was observed to extended further than the surrounding break surface.The characteristics of the break suggest material fatigue caused by kinking and tensile forces may have contributed to the formation of the split and break.Since the hub was found to be fully detached, the complaint is confirmed but the exact factors remain unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that on the morning of (b)(6) 2020 when using a powerpicc provena on a patient, one of the valves detached from the picc.There was no patient harm and the device was not connected to any fluids.Additional information received 11/4/2020: device was placed (b)(6) 2020 and removed (b)(6) 2020.

• Brand Name: POWERPICC SOLO PROVENA 5F TL
• 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: 10831716
• Report Number: 3006260740-2020-20501
• Device Sequence Number: 2828849
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: S1395108D3
• Device Catalogue Number: S1395108D3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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
• Patient Age: 63 YR
• Patient Weight: 133