MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LL 21GA 1-1/2IN TW

Catalog Number 302153

Device Problem Leak/Splash (1354)

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

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the syringe 10ml ll 21ga 1-1/2in tw experienced product damage/deformation with the device still considered operable.Product defect was noted during use.The following information was provided by the initial reporter: broken syringe.

Event Description

It was reported that the syringe 10ml ll 21ga 1-1/2in tw experienced product damage/deformation with the device still considered operable.Product defect was noted during use.The following information was provided by the initial reporter: broken syringe.

Manufacturer Narrative

H.6 investigation summary: one photo and one actual sample were received by our quality team for evaluation.Upon visual inspection, damage on the syringe barrel was observed; therefore, the incident can be verified.Probable root cause could be at the no needle eject gate station; the top guide plate adjusted lower to the transaction dial.As this caused the product tilted from the slot pocket resulted crashed and damaged by pocket dial and side guide during transition to outfeed dial process.The defect parts failed to remove effectively by production technician which resulted escapees to the next process.Action was taken, as fabricate new top guide plate mounting to secured alignment at needle eject station to prevent the syringe product tilted from the slot pocket on 31 october 2019.A device history record review found no non-conformances associated with this issue during production of this batch.The syringe barrel damaged during the transition to outfeed dial at syringe needle assembly process.H3 other text : see.H.10.

• Brand Name: SYRINGE 10ML LL 21GA 1-1/2IN TW
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9527782
• MDR Text Key: 179132680
• Report Number: 8041187-2019-01036
• 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: 01/27/2020

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 Catalogue Number: 302153
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other