MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD

Catalog Number 30773019

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 03/18/2019

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 2 syringes 2ml ls 23ga 1-1/4in dn emerald were found with bent tips before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "it was found the tip bent before using.".

Event Description

It was reported that 2 syringes 2ml ls 23ga 1-1/4in dn emerald were found with bent tips before use.The following information was provided by the initial reporter, translated from chinese to english: "it was found the tip bent before using.".

Manufacturer Narrative

Investigation: bd has been provided with the affected sample for catalog 30773019 lot 1804257 to investigate for this record.Visual inspection of the returned sample presented the tip bent, verifying the reported issue.The material used to manufacture emerald syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100% of the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.Based on this fact, bd believes that the syringe tip could bent because of storage conditions during manufacturing, if the barrel is still hot when other product is storage above it, that barrel could be damaged.After that, this bent tip was not detected by the primary packaging machine.Dhr showed no indication of the alleged defect.

• Brand Name: SYRINGE 2ML LS 23GA 1-1/4IN DN EMERALD
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8479877
• MDR Text Key: 147173331
• Report Number: 3002682307-2019-00229
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 30773019
• Device Lot Number: 1804257
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other