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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that while using unspecified bd¿ needle the syringe was broken.The following was recieved from the initial reporter: verbatim: xxx from xxx called in and stated that she had a customer notify her that he was having an issue with needles he received from xxx.The customer is stating that some of the syringe came in the box broken.Also the needle broke off in his arm.Bd ins syringe us 0.5 ml 8mmx31g xxx xxxx - xxx risk management dept.- wants to be contacted once we have talked to the customer.Customer stated he had 2 er visits due to needle stuck in arm.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to unknown batch number, no dhr can be completed.

Event Description

It was reported that while using unspecified bd¿ needle the syringe was broken.The following was recieved from the initial reporter: verbatim: xxx from xxx called in and stated that she had a customer notify her that he was having an issue with needles he received from xxx.The customer is stating that some of the syringe came in the box broken.Also the needle broke off in his arm.Bd ins syringe us 0.5 ml 8mmx31g xxx xxxx - xxx risk management dept.- wants to be contacted once we have talked to the customer.Customer stated he had 2 er visits due to needle stuck in arm.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17240256
• MDR Text Key: 318227040
• Report Number: 2243072-2023-01165
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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