MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD STPCK Q-SYTE RED 360DEG W/O NUT CAP NS; STOPCOCK

Catalog Number 395246

Device Problem Leak/Splash (1354)

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

Event Date 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use leakage occurred with a bd stpck q-syte red 360deg w/o nut cap ns.The following information was provided by the initial reporter, translated from (b)(6) to english: drug leaked.No info where the drug leaked from.

Manufacturer Narrative

Investigation summary: a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Leakage testing of the returned unit determined that a leak existed, and was the result of a separation of the septum from the housing of the device.Due to the nature of the leak and the fact that the device was used, the root cause for this complaint could not be determined at the conclusion of our review.Should a lot number become available, it will allow for a more accurate review of manufacturing records.Bd was not able to attribute this failure mode to the mfg process because the parameters in which the piece was manufactured cannot be reviewed since lot was not reported.

Event Description

It was reported that during use leakage occurred with a bd stpck q-syte red 360deg w/o nut cap ns.The following information was provided by the initial reporter, translated from japanese to english: drug leaked.No info where the drug leaked from.

• Brand Name: BD STPCK Q-SYTE RED 360DEG W/O NUT CAP NS
• 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
• MDR Report Key: 9156962
• MDR Text Key: 191040333
• Report Number: 9610847-2019-00602
• 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: 12/03/2019

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: 395246
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other