MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 10CM WHITE; INFUSION DEVICE

Catalog Number 394995

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8219554; medical device expiration date: 2021-07-31; device manufacture date: 2018-09-12.Medical device lot #: 8184805; medical device expiration date: 2021-06-30 ; device manufacture date: 2018-09-04.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the 3 way valve on a connecta plus3 10cm white broke off when trying to disconnect the infusion system.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8219554 & 8184805.Our records show that this is the only instance of this issue occurring in either production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, our quality engineers reviewed the sample submitted, during their evaluation they noted that the broken section that had been returned does not belong to a bd device.The connecta unit was found to operate with the expected parameters established for this device.Conclusion: bd was not able to duplicate the customer¿s indicated failure mode according evaluated samples, however, the broken pieces is not manufactured for bd site nogales, therefore, this complaint is not related to our manufacturing process.Quality records have been consulted for tracking and trending purposes and no issues are detected which means pretty low occurrence.

Event Description

It was reported that the 3 way valve on a connecta plus3 10cm white broke off when trying to disconnect the infusion system.

• Brand Name: CONNECTA PLUS3 10CM WHITE
• Type of Device: INFUSION DEVICE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8367769
• MDR Text Key: 137409385
• Report Number: 9610847-2019-00184
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other