MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTEGRA¿ SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: 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).The reported lots 2216568 and 2243842 do not match any material numbers associated with the reported product.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 2 unspecified bd integra¿ syringes each from the reported lots 2216568 and 2243842 failed to retract their needles during use.The following information was provided by the initial reporter: "the button is not retracting.".

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of batch: 2243842.The device history record review for lot number: 2216568 and previous investigations performed for this report show a potential manufacturing related issue was present.An in-depth analysis of the production process is currently in progress to identify a root cause for this potential issue and prevent further recurrence.Again, without the physical sample, the report could not be confirmed.

Event Description

It was reported that 2 unspecified bd integra¿ syringes each from the reported lots: 2216568 and 2243842 failed to retract their needles during use.The following information was provided by the initial reporter: "the button is not retracting.".

• Brand Name: UNSPECIFIED BD INTEGRA¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16076222
• MDR Text Key: 308247183
• Report Number: 2243072-2022-02253
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1