MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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

It was reported that during use of the unspecified bd syringe the tip of the needle broke off in patients leg.Two surgeries were performed to remove the cannulas.The following information was provided by the initial reporter: the needle had been broken twice and had to be surgically removed.

Manufacturer Narrative

Investigation: no samples (including photos) were returned as of 18 november 2019 therefore the complaint could not be confirmed and the root cause is undetermined.Cannot perform a dhr review due to unknown lot number.

Event Description

It was reported that during use of the unspecified bd¿ syringe the tip of the needle broke off in patients leg.Two surgeries were performed to remove the cannulas.The following information was provided by the initial reporter: the needle had been broken twice and had to be surgically removed.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9129770
• MDR Text Key: 162299517
• Report Number: 2243072-2019-02139
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention