MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD GW PAMP SAFE 20F; FEEDING TUBE

Model Number	003030
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 for evaluation.The investigation of the reported event is currently underway.(expiration date: 09/2020).
Event or Problem Description
It was reported that during gastrostomy feeding tube placement, the guidewire was allegedly unwound.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ptfe coated guidewire, in two pieces was returned for evaluation.Both segments of the guidewire had multiple bends and kinks along their lengths.The inner guidwire on one of the segments was exposed.The braiding of the guidewire on the other segment was unwound and loose.The investigation is confirmed for the alleged fracture of the guidewire core wire and the fraying of the outer wire of the guidewire.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: g4.H11: h3, h6 (results, 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 during gastrostomy feeding tube placement, the guidewire was allegedly unwound.There was no reported patient injury.

• Brand Name: BARD GW PAMP SAFE 20F
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9914302
• Report Number: 3006260740-2020-01124
• Device Sequence Number: 3272205
• Product Code: KNT
• UDI-Device Identifier: 00801741081170
• UDI-Public: (01)00801741081170
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K915841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: Health Professional
• Device Model Number: 003030
• Device Catalogue Number: 003030
• Device Lot Number: HUCX2693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1