MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 8 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT; PORT AND CATHETER ACCESSORIES

Catalog Number	0607780
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4: (expiration date: 01/2028).H11: section a: through f: the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the mid sheath was allegedly fractured.There was no reported patient injury.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the mid sheath was allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported fracture issue as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2028), g3.H11: h6 (result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one j-tip guidewire in a guidewire hoop, one introducer needle, and one 8.0fr peel-apart sheath with vessel dilator were returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.A split was noted on the center portion of the peel-apart sheath shaft and bunching was noted in split area.The distal tip of the loaded vessel dilator was noted to be deformed.An attempt to remove the vessel dilator from the peel-apart sheath was performed and retracted without resistance.Therefore, the investigation is confirmed for the reported fracture and identified deformation issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2028), g3, h2, h6 (device) h11: d4 (unique identifier (udi) #), h6 (method, result) h11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the mid sheath was allegedly fractured.There was no reported patient injury.

• Brand Name: 8 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19109829
• Report Number: 3006260740-2024-01766
• Device Sequence Number: 20773379
• Product Code: DYB
• UDI-Device Identifier: 00801741038358
• UDI-Public: (01)00801741038358(17)280131(10)REHQ2969
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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 Catalogue Number: 0607780
• Device Lot Number: REHQ2969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 09/21/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/16/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown