MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. C35J STOPCOCK Q-SYTE WHT 360DEG W/O NUT CAP NS

Catalog Number 395242

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a c35j stopcock q-syte wht 360deg w/o nut cap ns had incorrect flow volume.

Manufacturer Narrative

H.6.Investigation summary: when i confirmed the actual product, it seems that it was thinly coated near the tip of the drip needle, and adhesion of chemical liquid was recognized.In addition, as a result of confirming dripping, dropping abnormality was observed in which the grain climbed to the upper side of the drip needle without dropping as it was.Based on the contents of the offer and abnormal dropping of the actual product, during the continuous use of this product by the infusion pump in the drip control mode, this event caused the chemical solution to adhere to the drip needle, the dropping mouth portion became hydrophilic.It was estimated that overflow was due to abnormal drip caused by an increase in grain size per droplet.A dhr was not performed as the lot number is "unknown" for this complaint.

Event Description

It was reported that a c35j stopcock q-syte wht 360deg w/o nut cap ns had incorrect flow volume.

• Brand Name: C35J STOPCOCK 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
• MDR Report Key: 8317436
• MDR Text Key: 135703272
• Report Number: 9610847-2019-00131
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903952427
• UDI-Public: 382903952427
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395242
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other