MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. USHER SUPPORT CATHETER

Catalog Number	USH130AT
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 upon opening of the device package, an alleged foreign material (hair) was discovered within the pouch.Reportedly, another device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
The lot number has been 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 reported for this lot number and issue to date.One usher catheter was returned for evaluation.The returned catheter was in the inner packaging container in the original packaged position, however, the seal was noted to be open.A hair was identified surrounding the catheter.The investigation is inconclusive for the alleged foreign material as it cannot be confirmed the hair was introduced before the product was sealed.As the device was returned with the seal of the container open it is unknown if the hair was introduced at the user facility.Per inspection procedure, the product is to be inspected for hair in the sealed packaging.Therefore, the identified hair could have been introduced during manufacturing.Awareness training was completed at the manufacturing site to address the issue.The current ifu (instructions for use) states: warnings contents are supplied sterile, using ethylene oxide (eo), and non-pyrogenic.Do no use if sterile barrier is opened or damages.Precautions carefully inspect the catheter prior to use to verify that catheter has not been damages during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.(b)(4).
Event or Problem Description
It was reported that upon opening of the device package, an alleged foreign material (hair) was discovered within the pouch.Reportedly, another device was used to complete the procedure.There was no patient contact.

• Brand Name: USHER SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7387308
• Report Number: 2020394-2018-00322
• Device Sequence Number: 16417134
• Product Code: DQY
• UDI-Device Identifier: 00801741068027
• UDI-Public: (01)00801741068027
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Expiration Date: 10/28/2020
• Device Catalogue Number: USH130AT
• Device Lot Number: GFBW2947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1