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

Catalog Number 394601

Device Problem Leak/Splash (1354)

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

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold leaked during use.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2019 with a diagnosis of ¿multiple injuries¿.On (b)(6), 08; 10 nurses routinely replace the connecta, connect the new connecta and find that there is leakage at the screw interface of the connecta, immediately replace the new connecta, continue the relevant treatment.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8093733.Our records show that this is the only instance of this issue occurring in this 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.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.Bd will continue to monitor this issue and encourages you to submit your sample for review.

Event Description

It was reported that bd connecta¿ multiflo¿ 3-way multiple infusion manifold leaked during use.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6), 2019 with a diagnosis of ¿multiple injuries¿.On (b)(6), 08; 10 nurses routinely replace the connecta, connect the new connecta and find that there is leakage at the screw interface of the connecta, immediately replace the new connecta, continue the relevant treatment.

• Brand Name: BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
• Type of Device: CONNECTA
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9251204
• MDR Text Key: 191720228
• Report Number: 9610847-2019-00649
• 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: 12/04/2019

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: 394601
• Device Lot Number: 80937330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other