MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCKS

Catalog Number 394601

Device Problem Air/Gas in Device (4062)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: it was reported there was air introduced during the infusion.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo was reviewed, and some bubbles were observed in the fluid line.These bubbles are not caused by the product but are more related to use and the time of the connection, which can generate air in the lines.A device history record review was completed for provided material number 394601, lot 2248712.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capa¿s or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.To date, there have been no other similar events reported for this lot.Based on the investigation, bd was able to confirm the failure mode indicated by the customer but is attributed to the use of the product.H3 other text : see h.10.

Event Description

It was reported that during use with bd connecta¿ stopcocks air in the line.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) 2023 surgery anesthesiologist in the patient's operation, infusion of drugs to the patient with three, found that the three leakage, the intraoperative liquid has been intermittent air into the three, the replacement of no air into the three.Adverse events of medical devices were reported.

• Brand Name: BD CONNECTA¿ STOPCOCKS
• Type of Device: STOPCOCKS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159648
• MDR Text Key: 318106530
• Report Number: 9610847-2023-00146
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394601
• Device Lot Number: 2248712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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