MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PONSKY DUAL PORT FEEDING ADAPTOR, 20F; FEEDING DEVICE

Model Number	000333
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
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 device has been returned to the manufacturer and the evaluation is still pending.The investigation of the reported event is currently underway.(expiry date: 12/2099).
Event or Problem Description
It was reported that post feeding device implant, the adapter of the device allegedly was leaking.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 dual port feeding adapter was returned for evaluation.Visual and functional evaluations were performed.The investigation is confirmed for fluid leak as during functional testing, the device was infused through both ports with water using an in-house 10ml syringe; no leaks were noted and both the ports were then sealed and an in-house syringe was loaded into the distal end of the feeding tube adapter and light pressure was applied; a leak was noted from the larger port.A definitive root cause could not be determined based upon 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) did not find any product labeling inadequacy.H10: d4(expiry date: 12/2099),g4 h11: h6(result and conclusion) 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.
Event or Problem Description
It was reported that post feeding device implant, the adapter of the device allegedly was leaking.There was no reported patient injury.

• Brand Name: PONSKY DUAL PORT FEEDING ADAPTOR, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10612704
• Report Number: 3006260740-2020-03398
• Device Sequence Number: 19466925
• Product Code: KNT
• UDI-Device Identifier: 10801741080934
• UDI-Public: (01)10801741080934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: Lay User/Patient
• Device Model Number: 000333
• Device Catalogue Number: 000333
• Device Lot Number: HUDN2175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1