MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 1ML SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that during use with an unspecified bd 1ml syringe the needle and syringe would separate and leakage occurred.Patient only received partial dose, additional impact has not been obtained.The following information was provided by the initial reporter: mixed medicine fine, pulled syringe to uncap, needle and syringe separated.Reassembled.Pressed into skin to inject, separated again.Some medicine got in and some ran down leg.Partial dose given.

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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that during use with an unspecified bd 1ml syringe the needle and syringe would separate and leakage occurred.Patient only received partial dose, additional impact has not been obtained.The following information was provided by the initial reporter: mixed medicine fine, pulled syringe to uncap, needle and syringe separated.Reassembled.Pressed into skin to inject, separated again.Some medicine got in and some ran down leg.Partial dose given.

Manufacturer Narrative

H6: investigation summary as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history review could not be completed as no batch number was provided.

• Brand Name: UNSPECIFIED BD 1ML 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17467040
• MDR Text Key: 320638610
• Report Number: 2243072-2023-01381
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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
• Date Manufacturer Received: 08/10/2023
• 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