MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LS

Catalog Number 302143

Device Problems Material Discolored (1170); Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

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 100 syringe 10ml ls experienced product discoloration.The following information was provided by the initial reporter: it was found that the color of tyvek turned red after opening the shelf carton, which was different from the color used before.

Manufacturer Narrative

H.6.Investigation: sample evaluation: three (3) actual samples were returned for investigation in seal package.The samples were subjected to visual inspection, no abnormality was observed on syringe top web printing and the printing information on the package is clear and legible from the returned samples.All 3 samples were observed color change in graphic printing.Based on the dhr reviewed there were no abnormality during production run.A review of past year syringe process and there was no change in material used in syringe.Hence, root cause could not be determined.

Event Description

It was reported that 100 syringe 10ml ls experienced product discoloration.The following information was provided by the initial reporter: it was found that the color of tyvek turned red after opening the shelf carton, which was different from the color used before.

• Brand Name: SYRINGE 10ML LS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8595289
• MDR Text Key: 145114528
• Report Number: 8041187-2019-00358
• Device Sequence Number: 1
• Product Code: FMF
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 302143
• Device Lot Number: 8142313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other