MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL PORT FEEDING ADAPTER 20F; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	000333
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the cap of the feeding port adaptor became loose a few days after placement.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one 20 fr peg dual port feeding tube bifurcation adaptor was returned for evaluation.The feeding adaptor (large port) was patent to infusion and aspiration, though leaks were observed with low hydraulic back pressure and the large cap dislodged relatively easily.The medicine port branch (small port) was patent to infusion and aspiration with no leaks observed under low hydraulic back pressure.Applicable diameter measurements were taken of the ports/caps and found to be within the specified range.As the large cap was found to be loose and leaked, the investigation is confirmed for the reported cap fit issue.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Potential contributing factors include material degradation and excessive force.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that the cap of the feeding port adaptor became loose a few days after placement.There was no reported patient injury.

• Brand Name: DUAL PORT FEEDING ADAPTER 20F
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7712239
• Report Number: 3006260740-2018-01803
• Device Sequence Number: 1369454
• Product Code: KNT
• UDI-Device Identifier: 10801741080934
• UDI-Public: (01)10801741080934
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 000333
• Device Catalogue Number: 000333
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1