MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 WHITE BLEND; STOPCOCK, I.V. SET

Catalog Number 394900

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that bd connecta plus3 white blend had foreign matter the following information was provided by the initial reporter; customer reported that a black mold-like foreign substance is adhering to the cap of a three-way stopcock.Also, brownish foreign matter is seen as well.Please investigate on the foreign substance, its effect on the body, and the reason for the foreign substance.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Our quality engineer inspected the 4 photos and 1 sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample and photos.Analysis of the sample and photos showed that there was embedded foreign material in the cap of the sample.Bd determined that the cause of the failure was related to the molding process.The material was determined to be a non-foreign, burnt particulate resin.These specks are a result of material build up on the barrel/screw breaking free during the molding process.Molds are purged between lots to reduce buildup; however, one lot can sometimes take up to ten days to produce.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Event Description

No additional information provided.

• Brand Name: BD CONNECTA PLUS3 WHITE BLEND
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18221449
• MDR Text Key: 329164792
• Report Number: 9610847-2023-00338
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903949007
• UDI-Public: (01)00382903949007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394900
• Device Lot Number: 3012464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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