MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 30GA 1/2IN UF 10BAG; PISTON SYRINGE

Model Number 328411

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

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 has been reported that the bd¿ syringe 1.0ml 30ga 1/2in uf 10 bag has been found experiencing three occurrences of the hub separating from the device during use.The following has been provided by the initial reporter: it was reported that the pet owner reported she found detached needle hub in the needle shield in the poly bag.Verbatim: issue: pet owner reported she found detached needle hub in the needle shield in the poly bag.It happened with other 2 bags with 2 syringes total.Sample available.Incident date: (b)(6), occurence - 1, item# 328411, lot# 8302725, manufactured date- 2018-12-01, expiration date - 2023-11-30.Pet owner uses new needle each time of pets injection.

Manufacturer Narrative

Investigation: customer returned (1) 1cc, 12.7mm, 30g syringe in an open poly bag from lot # 8302725.Customer states that she found detached needle hub in the needle shield in the poly bag.The syringe was returned with the barrel tip broken off and separated from the barrel.A review of the device history record was completed for batch# 8302725.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.The syringes were packaged at the form, fill, and seal operation, the sealing jaw forms the polybag bottom, as well as the top of the previous bag.Syringes are gravity fed into the polybag via a tube.Between the sealing jaws resides a cutoff knife that severs the polybag roll.The compression of the sealing jaws and the cutoff action completes the finished polybag.There were no quality notification or maintenance dispatches during the production of this batch that pertained to the complaint.Therefore no root cause can be determined.

Event Description

It has been reported that the bd¿ syringe 1.0ml 30ga 1/2in uf 10bag has been found experiencing three occurrences of the hub separating from the device during use.The following has been provided by the initial reporter: it was reported that the pet owner reported she found detached needle hub in the needle shield in the poly bag.Verbatim: issue: pet owner reported she found detached needle hub in the needle shield in the poly bag.It happened with other 2 bags with 2 syringes total.Sample available.Incident date: (b)(6) 2019.Occurrence-1.Item# 328411.Lot# 8302725.Manufactured date- 2018-12-01.Expiration date-2023-11-30.Pet owner uses new needle each time of pets injection.

• Brand Name: BD SYRINGE 1.0ML 30GA 1/2IN UF 10BAG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9534203
• MDR Text Key: 193654193
• Report Number: 1920898-2019-01490
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 8302725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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
• Patient Outcome(s): Other