MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM TUBING SETS; LAPAROSCOPIC, GENERAL & PLASTIC SURGERY

Catalog Number 5552002

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Visual inspection demonstrates a hair inside of the sealed product packaging.The foreign material does not extend beyond the seal which remains intact.Based on the investigation performed and sample evaluation, the foreign hair presented during the manufacturing process prior to the packaging being sealed.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2020.Awareness training was provided to the appropriate associates.

Event Description

As reported, there was a hair partially inside the unopened package of an x-stream tubing set w/ nd trumpet valve.It is alleged that the unopened packaging was contaminated.The device was not used on the patient.

• Brand Name: X-STREAM TUBING SETS
• Type of Device: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10264852
• MDR Text Key: 198691575
• Report Number: 1213643-2020-06579
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 5552002
• Device Lot Number: JUEN2741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1