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

Catalog Number UNKNOWN

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/10/2023

Event Type  malfunction  

Event Description

It was reported that the unspecified bd¿ syringe shield was loose in the bag, leaving the needle exposed to puncture the hand of the pharmacist through the packaging.The following information was provided by the initial reporter: received voicemail from pharmacist stating he stuck the palm of his hand on an exposed needle.Stated, the needle shield that should have been covering the needle was loose in the bag stated, the package was sealed.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.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.

Event Description

It was reported that the unspecified bd¿ syringe shield was loose in the bag, leaving the needle exposed to puncture the hand of the pharmacist through the packaging.The following information was provided by the initial reporter: received voicemail from pharmacist stating he stuck the palm of his hand on an exposed needle.Stated, the needle shield that should have been covering the needle was loose in the bag stated, the package was sealed.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 2206107.All inspections were performed per the applicable operations qc specifications.

• Brand Name: UNSPECIFIED BD¿ 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 ; 8448235433
• MDR Report Key: 16897726
• MDR Text Key: 314891896
• Report Number: 2243072-2023-00771
• 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,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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: Health Professional
• 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: 04/10/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/17/2023
• 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