MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ¿ SYRINGE WITH NEEDLE

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the unspecified bd¿ syringe with needle there was an issue with needle breaking.It was also reported that the patient was hospitalized and required surgery.

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr due to unknown lot number.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.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.

Event Description

It was reported with the use of the unspecified bd syringe with needle there was an issue with needle breaking.It was also reported that the patient was hospitalized and required surgery.

• Brand Name: UNSPECIFIED BD ¿ SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7807487
• MDR Text Key: 117958100
• Report Number: 2243072-2018-01167
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention