MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL 25X1 RB; PISTON SYRINGE

Catalog Number 309581

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no: 309581, batch no: unknown.It was reported by the consumer that they could not draw medication with the syringe 3ml ll w/ndl 25x1 rb.Consumer tried with one syringe and when they tried the second syringe, b-12 leaked outside hub area.The following information was provided by the initial reporter: stated could not draw medication with 1 syringe.Tried second syringe, b-12 leaked outside hub area.

Event Description

Material no: 309581, batch no: unknown.It was reported by the consumer that they could not draw medication with the syringe 3ml ll w/ndl 25x1 rb.Consumer tried with one syringe and when they tried the second syringe, b-12 leaked outside hub area.The following information was provided by the initial reporter: stated could not draw medication with 1 syringe.Tried second syringe, b-12 leaked outside hub area.

Manufacturer Narrative

H.6.Investigation: two loose and six sealed 3ml syringes with needles were received.The packaged product was confirmed to be from batch #8155884 (p/n 309581).The two loose samples were visually evaluated.No defects were observed.Small amount of fluid was seen in the fluid path of the tip, as well as small amount of unidentified residue in the luer collar around the needle hub ears.It was found that the needles were not fully attached and could be turned clockwise anywhere from 1/8 to 1/4 of a turn.The six sealed syringes were tested for leakage at luer per procedure.All six syringes passed with no leakage observed in any of the samples.It is important to make sure the needle is fully connected to the syringe prior to use by verifying the luer lock connection.The reported defect was not identified in the samples received.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 reported defect was not identified in the samples received.H3 other text : see h.10.

• Brand Name: SYRINGE 3ML LL W/NDL 25X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8847359
• MDR Text Key: 153847690
• Report Number: 1213809-2019-00789
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 309581
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other