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

Model Number	000333
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that some post placement procedure, the cap on the feeding adapter became loose.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one ponsky dual port feeding tube adapter was returned for evaluation.Gross visual evaluation was performed.The catheter, bolster and ponsky dome were noted to be missing.The caps on the device appeared intact.Based on the sample evaluation, the investigation is unconfirmed for the loose cap issue.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) did not find any product labeling inadequacy.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.H3 other text : see h10.
Event or Problem Description
It was reported that some time post placement procedure, the cap on the feeding adapter became loose.There was no reported patient injury.
Event or Problem Description
It was reported that approximately eight days post device placement procedure, the cap on the feeding adapter became loose.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one ponsky dual port feeding tube adapter was returned for evaluation.Gross visual evaluation was performed.All closure straps and plugs on the device appeared intact as well all ports.Both closure straps and plugs of the device were inserted into their ports with applied pressure; no issue was noted.Ports were examined while closed and both did not appear to be loose.Therefore, the investigation is inconclusive for the reported loose cap issue as the exact circumstances at the time of reported event was unknown and sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm this event.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) did not find any product labeling inadequacy.H10: b5, g3.H11: h6 (result, conclusion).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 DUAL PORT FEEDING ADAPTOR, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11804306
• Report Number: 3006260740-2021-01777
• Device Sequence Number: 4345239
• 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: 2021
• 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): 02/07/2022

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: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 02/07/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/09/2021; 02/09/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown