MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; STOPCOCK

Catalog Number 394601

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8093747, medical device expiration date: 2021-03-31, device manufacture date: 2018-05-25.Medical device lot #: 8093734, medical device expiration date: 2021-03-31, device manufacture date: 2018-05-16.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold had a sterility breach.No serious injury or medical intervention was reported.Verbatim: "a total of (b)(4) products in (b)(4) batches were found dialysis paper of unit package yellower and dampened".

Manufacturer Narrative

Investigation: a device history review was conducted for lot numbers 8093734 & 8093747.Our records show that this is the only instance of this issue occurring in either lot.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 review of the samples provided by your facility were found to be within the tolerance range visual appearance.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold had a sterility breach.No serious injury or medical intervention was reported.Verbatim: "a total of 2,500 products in two batches were found dialysis paper of unit package yellower and dampened.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot numbers 8093734 & 8093747.Our records show that this is the only instance of this issue occurring in either lot.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold had a sterility breach.No serious injury or medical intervention was reported.Verbatim: "a total of 2,500 products in two batches were found dialysis paper of unit package yellower and dampened.".

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8390739
• MDR Text Key: 139202867
• Report Number: 9610847-2019-00194
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946013
• UDI-Public: 382903946013
• 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,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other