MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN)(135 CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that peel-away sheath is "faulty".Patient was reported as fine after event.No other information was provided.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw1290 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of the peel away sheath being faulty is inconclusive due to the poor sample condition.One powerpicc kit was returned for evaluation.An initial visual observation showed that the kit was returned opened and everything was returned in the kit except for the microintroducer.There were no use residues throughout the kit, and there was nothing remarkable observed regarding the products returned in the kit.Based on the observations of the returned sample, the complaint of a faulty peel away sheath in the powerpicc kit is inconclusive as the microintroducer was not returned with the rest of the kit and could not be evaluated.Possible causes of failure could be manufacturing related splits in the sheath before user interface, or insertion angle of the device into the patient; however, a conclusion cannot be made at this time due to the returned sample condition.
Event or Problem Description
It was reported that peel-away sheath is "faulty".Patient was reported as fine after event.No other information was provided.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN)(135 CM GUIDEWIRE)
• 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: 16071068
• Report Number: 3006260740-2022-05912
• Device Sequence Number: 15026430
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 3276135
• Device Lot Number: REFW1290
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 04/13/2023
• 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