MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number 309581

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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.(b)(4).

Event Description

It was reported that the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle experienced a loose needle and leakage.The following information was provided by the initial reporter: material no: 309581, batch no: 0065046.Consumer reported, when she was taking her b-12 injection, some of it leaked onto the injection site.Stated, she did not get the complete dose.Stated, the needle did seem loose.Stated, she takes the shot every 28 days, so she does not have anymore to try again, she was never told the needle needed to be "secured or seated" before using the "luer lock detachable" syringe.1 syringe affected.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/5/2021.H.6.Investigation: one 3ml syringe with needle attached in an opened blister pack from batch 0065046 (p/n 309581) was received and evaluated.The sample appeared to be manipulated as visible red fluid droplets were present in the tip of the syringe and hub.The reported defect could not be confirmed based on the sample received.Physical unused samples for the same batch are necessary for leakage testing.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.

Event Description

It was reported that the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle experienced a loose needle and leakage.The following information was provided by the initial reporter: material no: 309581 batch no: 0065046.Consumer reported, when she was taking her b-12 injection, some of it leaked onto the injection site.Stated, she did not get the complete dose.Stated, the needle did seem loose.Stated, she takes the shot every 28 days, so she does not have anymore to try again, she was never told the needle needed to be "secured or seated" before using the "luer lock detachable" syringe.1 syringe affected.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP 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: 11386779
• MDR Text Key: 233820254
• Report Number: 1213809-2021-00109
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 309581
• Device Lot Number: 0065046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1