MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PONSKY PEG KIT, 20F; FEEDING TUBE

Model Number	006035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that post implant, the device allegedly broken.It was further reported that device was removed from the patient.There was no reported on patient injury.
Event or Problem Description
It was reported that post implanted procedure approximately, the device allegedly broken.It was further reported that device was removed from the patient.There was no reported on patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one dual port feeding adapter was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported feeding adapter damage, as the feeding port cap was returned fractured and the feeding port cap fracture appeared jagged.A definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) found that the product labeling was inadequate.H11: section a through f ¿ the information provide 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.

• Brand Name: PONSKY PEG KIT, 20F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10827394
• Report Number: 3006260740-2020-20463
• Device Sequence Number: 4011659
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 006035
• Device Catalogue Number: 006035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 05/21/2021
• 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