MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II¿ SYRINGE WITH NEEDLE; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 300847

Device Problem Difficult to Advance (2920)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Medical 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 bd discardit ii¿ syringe with needle had difficult plunger movement.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the bd discard it ii syringe with needle had difficult plunger movement.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

No samples or photographs was returned for investigation.The team analyzed the marking & assembly process and found that all process controls are in place and in working condition.The functional (sustaining & separation) forces are measured for syringes during the manufacturing of lot# 18b2311.All the forces were found within the specification limit (sustaining force = 0.750kgf & separation force = 1.0 kgf).A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: unable to determine a root cause.Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

• Brand Name: BD DISCARDIT II¿ SYRINGE WITH NEEDLE
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7743846
• MDR Text Key: 116051197
• Report Number: 2243072-2018-01045
• 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: 08/29/2018

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: No Information
• Device Catalogue Number: 300847
• Device Lot Number: 18B2311
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other