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

Catalog Number 394601

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

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that bd connecta plus3 white pegs had foreign matter the following information was provided by the initial reporter; biddy's infusion tee opened the package and found a foreign substance inside.

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 3 photos and 1 sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection and testing of the sample and photos.The returned photos show a brown material in the tap of the device.Analysis of the physical sample showed that the brown material was embedded into the device and could not interfere with the functioning of the device.Bd determined that the cause of the failure was related to our molding process.This type of defect is likely to occur during the molding process of the devices if a foreign material or speck of burn resin from a prior device is included in the liquid phase of the resin mixture during the molding process of this unit.The brown speck will then melt and solidify with the unit as it is manufactured.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.

Event Description

No additional information received.

• Brand Name: BD CONNECTA PLUS3 WHITE PEGS
• 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: 18233983
• MDR Text Key: 329708550
• Report Number: 9610847-2023-00343
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 3032035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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