MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG SAFETY 20FR PULL, MEDICON; FEEDING DEVICE

Model Number	006035
Medical Device Problem Codes	Crack (1135); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 006035 feeding device allegedly experienced some time post percutaneous endoscopic gastrostomy (peg) placement, the strap between the feeding adapter and the lid was allegedly torn.It was further reported that the peg was removed and replaced with another peg.This report was received from one source.This event involved one male patient, age and weight were not provided.Patient had no reported patient injury.
Additional Manufacturer Narrative
The malfunction was identified for crack and not identified for defective component.The lot number for the malfunction was not provided.The device has been returned for evaluation; the investigation is confirmed for crack.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 006035 feeding device allegedly experienced a crack.This report was received from one source.This event involved one male patient, age and weight were not provided.Patient had no reported patient injury.
Additional Manufacturer Narrative
H10: the malfunction was identified for crack and not identified for defective component.The lot number for the malfunction was not provided.The device has been returned for evaluation; the investigation is confirmed for crack.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: through a communication with the u.S.Food and drug administration on 09/16/2019, it was identified that the procode knt is no longer eligible for voluntary malfunction summary reporting (vmsr).However, the initial emdr was previously submitted in the prior quarter when the procode was eligible for vmsr.Therefore, this report is the second supplemental to the initial report.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
This report summarizes one(1) malfunction event.A review of the events indicated that model 006035 feeding device allegedly experienced a crack.This report was received from one source.This event involved one male patient, age and weight were not provided.Patient had no reported patient injury.

• Brand Name: PEG SAFETY 20FR PULL, MEDICON
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; lot #1, road #3, km 79.7; salt lake city UT 84116
• MDR Report Key: 8533417
• Report Number: 3006260740-2019-01112
• Device Sequence Number: 19312734
• Product Code: KNT
• UDI-Device Identifier: 00801741081187
• UDI-Public: (01)00801741081187
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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: No Information
• Device Model Number: 006035
• Device Catalogue Number: 006035
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019; 03/31/2020
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019; 04/14/2020
• Patient Sequence Number: 1