MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SHER-I-BRONCH ACCESSORY PACK; ENDOBRONCHIAL ACCESSORY PACK

Catalog Number 5-16142

Device Problem Crack (1135)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

The customer alleges that the pt connector cracked when it was being assembled.The alleged issue was detected during pre-testing.No pt injury.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.A capa# (b)(4) has been opened by the manufacturing site to address similar issues with the product.Customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.

• Brand Name: HUDSON SHER-I-BRONCH ACCESSORY PACK
• Type of Device: ENDOBRONCHIAL ACCESSORY PACK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill rd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4742242
• MDR Text Key: 18091018
• Report Number: 3003898360-2015-00302
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5-16142
• Device Lot Number: 73J1400258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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