MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿-W WINGED YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 381312

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use of the bd insyte¿-w winged yel 24ga x 0.75in the needle was through the catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: a week ago we sold 3 needles bd insyte w cath 24g 0.7x19mm yellow to a patient of ours.This patient buys these needles very often.She came back this week with 1 needle with the complaint that the tube around the needle was snapped.I have the appropriate needle here with us in the pharmacy.Lot number not known, because she has thrown away the plastic packaging.

Event Description

It was reported that before use of the bd insyte¿-w winged yel 24ga x 0.75in the needle was through the catheter.The following information was provided by the initial reporter, translated from dutch to english: a week ago we sold 3 needles bd insyte w cath 24g 0.7x19mm yellow to a patient of ours.This patient buys these needles very often.She came back this week with 1 needle with the complaint that the tube around the needle was snapped.I have the appropriate needle here with us in the pharmacy.Lot number not known, because she has thrown away the plastic packaging.

Manufacturer Narrative

Investigation: a picture was provided making it able to verify the failure of needle through catheter.The probable root cause, this would have occurred during product application when the product was manipulated.Batch number was unavailable and hence unable to perform the dhr review.

• Brand Name: BD INSYTE¿-W WINGED YEL 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9315429
• MDR Text Key: 178608542
• Report Number: 8041187-2019-00917
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813125
• UDI-Public: 30382903813125
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other