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

Catalog Number UNKNOWN

Device Problem Fracture (1260)

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

Event Date 08/21/2022

Event Type  malfunction  

Event Description

It was reported that the unspecified bd glass syringe experienced device damage while still considered operable.The following information was provided by the initial reporter, translated from chinese: the patient underwent cesarean section under spinal epidural anesthesia at 8:30.Anesthesia puncture was routinely performed before the operation.Using the glass syringe, the water could not be pumped, and it was broken with a little force.Only reopen the package and perform anesthesia.

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.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.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.

Manufacturer Narrative

Per internal clarification, it has been discovered that the device reported is not manufactured by bd.This report and the initial submission, (mfr report #: 2243072-2022-01583) may therefore be disregarded.H3 other text : see h10.

Event Description

It was reported that the unspecified glass syringe experienced device damage while still considered operable.The following information was provided by the initial reporter, translated from chinese: the patient underwent cesarean section under spinal epidural anesthesia at 8:30.Anesthesia puncture was routinely performed before the operation.Using the glass syringe, the water could not be pumped, and it was broken with a little force.Only reopen the package and perform anesthesia.

• Brand Name: UNSPECIFIED BD GLASS 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: 15469916
• MDR Text Key: 302005123
• Report Number: 2243072-2022-01583
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/04/2022
• 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