MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
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.Device not returned for evaluation.
Event or Problem Description
It was reported that the catheter leaked from the connector (gray part).A new device was used.
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 review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leaking from the connector is confirmed; however, the root cause is unknown.One 4 fr groshong nxt clearvue catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal connector piece was returned separate from the catheter, which was returned on the cannula of the proximal connector piece.Mechanical damage was observed on the gray plastic portion of both sides of both connector pieces.The proximal connector piece with the attached catheter was flushed and pressurized with a 12 ml syringe of water and no leaks were found.Once the catheter and connector pieces were assembled, the assembly was pressurized and the catheter almost immediately detached from the connector.The distal connector piece was bisected, and the internal compression sleeve which locks the catheter onto the cannula of the proximal connector piece when the connector pieces are assembled was found to be completely missing.While the leakage from the connector appears to have been caused by a missing compression sleeve, it was not possible to determine when or where the compression sleeve went missing.Therefore, the cause of the alleged leaking is unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that the catheter leaked from the connector (gray part).A new device was used.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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: 10995950
• Report Number: 3006260740-2020-20894
• Device Sequence Number: 17242329
• Product Code: LJS
• UDI-Device Identifier: 00801741027932
• UDI-Public: (01)00801741027932
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: N/A
• Device Catalogue Number: 3275155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 03/15/2021
• 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