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

Catalog Number 395242

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 1045 stpcks q-syte wht 360deg w/o nut cap ns were found with "burrs" on them.The following information was provided by the initial reporter, translated from (b)(6) to english: "burrs were found on (b)(4) products.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 0007735.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, small defects with the molding of the product were observe.It is possible for defects such as this to occur if minor abnormal adjustments occur within the manufacturing process; however, these abnormalities rarely occur during production.See h.10.

Event Description

It was reported that 1045 stpcks q-syte wht 360deg w/o nut cap ns were found with "burrs" on them.The following information was provided by the initial reporter, translated from japanese to english: "burrs were found on 1045 products.".

• Brand Name: STPCK Q-SYTE WHT 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: 11244884
• MDR Text Key: 229627962
• Report Number: 9610847-2021-00042
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395242
• Device Lot Number: 0007735
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1