MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problems Crack (1135); Microbial Contamination of Device (2303); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that during a gastric banding procedure, the plastic packaging had a crack in it and therefore was contaminated.Case completed with another device of the same product code.There were no patient consequences reported.One device will be returned.

Manufacturer Narrative

(b)(4): information anticipated, but unavailable at this time.No device received for analysis at time of submission of 3500a when additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).Additional information the following components were returned: the curved band (lot #zlnbcb) with 60 cm of catheter and the one way valve.The velocity port ( lot #znlbbj) with the red safety cap.The port applier.The locking connector and with the tubing strain relief.No tyvek, lid or plastic packaging were returned for evaluation, consequently it is not possible to confirm the event description.A device history record (dhr) review was performed, and no discrepancies were recorded during the manufacturing process.A review of the manufacturing process was performed and is noted that all products are 100% visual inspected prior to release, therefore it is unlikely that a manufacturing issue contributed to the reported event.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4097091
• MDR Text Key: 4700865
• Report Number: 3005992282-2014-00054
• Device Sequence Number: 1
• Product Code: LTI
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: RLZB32
• Device Lot Number: ZNNBBM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1