MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED GN 18GA X 1.88IN; INTRAVASCULAR CATHETER

Model Number 381347

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that insyte-w winged gn 18ga x 1.88in had incorrect label information.This occurred on 100 occasions.The following information was provided by the initial reporter: two boxes (100 needles) needles were given to (b)(6) on (b)(6) 2020.The feedback boxes were stamped as follows during inspection.The hospital refused to accept them.

Event Description

It was reported that insyte-w winged gn 18ga x 1.88in had incorrect label information.This occurred on 100 occasions.The following information was provided by the initial reporter: two boxes (100 needles) needles were given to (b)(6) hospital on october 20.The feedback boxes were stamped as follows during inspection.The hospital refused to accept them.

Manufacturer Narrative

H6: investigation summary.One photo was received by manufacturing plant for evaluation.From the photo, a red stamp stain was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The photos were sent to (b)(4) for investigation.The (b)(4) investigated this issue and found: 1.(b)(4) does not have the business of stamping on products, and (b)(4) doesn't have any stamp like customer feedback.2.(b)(4) didn't received any complaint about this red stamp from other customers.3.We checked this stamp carefully and found there was chinese city name "(b)(6) " and area code of (b)(6).4.For sku381347 lot 9238469, we only sold this batch to this complaint dealer, no other dealer in (b)(6).No record of foc for this batch shipped to (b)(6).5.For this batch, there is not any record of return, so it can't be stamped by other dealer and reshipped by (b)(4).6.For this batch, we have 300ea stock in (b)(4) and there is no seal on the shelf pack.Therefore, the red stamp was out of bd's responsibility.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see h.10.

• Brand Name: INSYTE-W WINGED GN 18GA X 1.88IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10892436
• MDR Text Key: 217987600
• Report Number: 8041187-2020-00774
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813477
• UDI-Public: 30382903813477
• 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: 12/30/2020

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 Expiration Date: 08/31/2024
• Device Model Number: 381347
• Device Catalogue Number: 381347
• Device Lot Number: 9238469
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1