MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEG CLEANING BRUSH; TUBE, GASTRO-ENTEROSTOMY

Catalog Number	000396
Medical Device Problem Codes	Component Falling (1105); Disconnection (1171)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned for evaluation.
Event or Problem Description
It was reported that the tip cover was disconnected from the cleaning brush during cleaning ponsky n.B.R.Catheter.The tip cover dropped off in the body.In the opinion of the facility, the facility will wait until the tip cover is eliminated from the body.
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a detached flexible tip from the peg cleaning brush was confirmed, but the cause is unknown.One peg cleaning brush was returned for investigation.The returned peg cleaning brush showed that the brush was manufactured correctly.The bristles were adhered within the tip and adhesive was noted to be covering the distal end of the twisted wire where the flexible tip was attached.The cylindrical shape of the adhesive layer that covers the twisted wire indicates that the flexible tip tubing had been attached to the tip.The flexible tip tubing was not returned for investigation.The outside diameter (od) of the adhesive layer at the distal tip was measured with calipers and was found to be within specification for the inner diameter (id) of the flexible tip tubing.It was reported that the flexible tip tubing detached during use and dropped in the body.Since the tubing was not returned for investigation, the exact cause of the detachment is unknown.As it appears that the product was manufactured correctly, this is most likely a use related incident.

• Brand Name: PEG CLEANING BRUSH
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6139558
• Report Number: 3006260740-2016-00636
• Device Sequence Number: 786532
• Product Code: KGC
• UDI-Device Identifier: 0080174086816
• UDI-Public: (01)0080174086816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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 Catalogue Number: 000396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1