MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER DL RADIOLOGY BT 135CM GW; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by healthcare professional "we had a hub fall off a picc on an inpatient today.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw2367 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "we had a hub fall off a picc on an inpatient today.".
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc catheter.Usage residues were observed throughout the sample.A complete break was observed in the purple-leured extension tubing.The proximal fragment, including the purple luer adapter was not returned for evaluation.Microscopic inspection of the proximal end of the purple-luered extension tube revealed a glossy surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling was observed in the vicinity of the break.The fracture features were consistent with damage accumulated through material fatigue.Material fatigue occurs when repetitive mechanical stresses such as twisting and kinking gradually cause a fracture to form and propagate in the catheter material.It could not be determined an additional unidentified factor(s) also contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: POWERPICC FT CATHETER DL RADIOLOGY BT 135CM GW
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13359073
• Report Number: 3006260740-2022-00057
• Device Sequence Number: 1675219
• Product Code: LJS
• UDI-Device Identifier: 00801741027956
• UDI-Public: (01)00801741027956
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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): 03/30/2022

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: 3275335F
• Device Lot Number: REFW2367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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