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

Catalog Number 394600

Device Problem Defective Component (2292)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 25 bd connecta¿ stopcocks were damaged, but still operable.The following information was provided by the initial reporter: "cap of bd connecta is not well open".

Event Description

It was reported that 25 bd connecta¿ stopcocks were damaged, but still operable.The following information was provided by the initial reporter: "cap of bd connecta is not well open.".

Manufacturer Narrative

H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

Event Description

It was reported that 25 bd connecta¿ stopcocks were damaged, but still operable.The following information was provided by the initial reporter: "cap of bd connecta is not well open".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-03-01 h6: investigation summary our quality engineer inspected the 13 samples submitted for evaluation.The reported issue was confirmed upon inspection and testing of the samples.During testing 3 of the samples were found to be out of manufacturing specifications.Bd determined that the cause of the failure was most likely associated to the manufacturing process, but it is also important to note that since the samples were returned in a used state there is a possibility misuse could have contributed to the defect.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review could not be performed since a valid lot number was not supplied.H3 other text : see h10.

• Brand Name: BD CONNECTA¿ STOPCOCK
• Type of Device: STOPCOCK
• 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 ; 8015296192
• MDR Report Key: 13440587
• MDR Text Key: 285769766
• Report Number: 9610847-2022-00039
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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