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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer name city and state and manufacturer contact office and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Date of event is unknown; awareness date has been used for this.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using unspecified bd insulin syringe the cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter: some needles break off and remain in their skin when they inject.

Manufacturer Narrative

H6: investigation summary: no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (2) photos, reporting 1 ml syringe needle dull, harm/bruising, breaks off during use, and foreign matter (dots).Based on the photo evidence and follow-up communications embecta was not able to confirm the reported failures as no physical samples are received.The foreign matter (dots) are related to the product manufacturing lines and does not impact the product quality or specifications.Due to the batch being unknown, no dhr review can be completed.The root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

Event Description

It was reported while using unspecified bd insulin syringe the cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter: some needles break off and remain in their skin when they inject.

• Brand Name: UNSPECIFIED BD INSULIN 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: 16570276
• MDR Text Key: 312026554
• Report Number: 2243072-2023-00422
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• 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: 06/22/2023
• 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