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

Model Number	006035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2021).
Event or Problem Description
It was reported that some time post feeding tube placement during exchanging the catheter, the bumper allegedly came off.It was further reported that the bumper left in the patient body was removed using endoscope.The health injury to the patient was unknown.
Event or Problem Description
It was reported that some time post feeding tube placement during exchanging the catheter, the bumper allegedly came off.It was further reported that the bumper left in the patient body was removed using endoscope.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one ponsky device returned in three segments was returned for evaluation.Gross visual and microscopic visual testing were performed.The investigation is confirmed for detachment issue as the ponsky dome was noted to be separated from the distal end of the catheter segment.A definitive root cause could not be determined based upon the available information.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 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.

• Brand Name: PONSKY PEG KIT, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11559287
• Report Number: 3006260740-2021-00952
• Device Sequence Number: 20029094
• 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): 08/12/2021

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: HUEU1388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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