MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 12/09/2019

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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that one unspecified bd¿ piston syringe has been found experiencing blocked plunger rod movement before use.The following has been provided by the initial reporter: she was trying to say that the plunger was stuck and she was unable to press it down to perform the injection.

Manufacturer Narrative

Investigation summary: no sample received.As samples and batch number are unavailable, no further investigation will be carried out.A full root cause analysis could not be conducted with the available information and is closed without a conclusion.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer.

Event Description

It has been reported that one unspecified bd¿ piston syringe has been found experiencing blocked plunger rod movement before use.The following has been provided by the initial reporter: she was trying to say that the plunger was stuck and she was unable to press it down to perform the injection.

• Brand Name: UNSPECIFIED BD PISTON SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9521874
• MDR Text Key: 177849427
• Report Number: 2243072-2019-02900
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other