MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number 309581

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd syringe with bd precisionglide¿ needle pulled out during injection.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 309581, batch no.: unknown.It was reported that there was an issue with a 3ml precision glide syringe.It was clarified that the needle came out of the syringe during injection.

Manufacturer Narrative

The following fields have been updated with corrections: medical device expiration date: 2022-10-31.Medical device lot #: 7308801.Device available for eval?: yes.Returned to manufacturer on: 2019-05-20.Device return to manuf.?: yes.Device eval by manuf.?: yes.Investigation: one 3ml syringe with needle in an opened blister pack from batch #7308801 (p/n 309581) was received and evaluated.The sample contained a few small red droplets in the needle hub, the bottom of the barrel and in the luer.The collar and luer of the syringe as well as the hub of the needle assembly were visually inspected with no defects observed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect the needle assembly may loosen from the syringe during shipment.The connection should always be checked prior to use.Root cause not defined since defects were not confirmed in the sample received.No corrective actions recommended since product defect was not confirmed.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd syringe with bd precisionglide¿ needle pulled out during injection.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 309581 batch no.: unknown.It was reported that there was an issue with a 3ml precision glide syringe.It was clarified that the needle came out of the syringe during injection.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that bd syringe with bd precisionglide¿ needle pulled out during injection.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 309581 batch no.: unknown.It was reported that there was an issue with a 3ml precision glide syringe.It was clarified that the needle came out of the syringe during injection.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8565806
• MDR Text Key: 145778022
• Report Number: 1213809-2019-00489
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: 30382903095811
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 309581
• Device Lot Number: 7308801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other