MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number 928857

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9231296.Medical device expiration date: 2024-09-30.Device manufacture date: 2019-08-19.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.H.6.Fda device code: 1354, 1069.Fda patient code: 2687".

Event Description

It was reported that a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use, and a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle shield was hard to remove and one syringe that the needle hub separated when the shield was removed.Also, one syringe where the needle broke off into the consumer's stomach, but was able to remove the needle with tweezers.Verbatim: consumer reported found 5-6 syringes needle shield hard to remove consumer reported found 1 syringe shield hard to remove when removed the needle hub went with it.Lot #: 9231296 catalog#: 928857 date of event: (b)(6) 2021 needle hub removed with shield removal date of event unknown for the 5-6 syringes shields hard to remove samples status awaiting sample.Consumer reported 1 syringe when injected into stomach the needle broke off into stomach/site.She was able to remove with tweezers on her own.Denied reuse of needles.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-09.H6: investigation summary.Customer returned (1) 3/10cc syringe.Customer states that the needle broke off into the consumer's stomach.The returned syringe was examined and no broken cannula was observed.Customer returned (1) 1/2cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 9231296.Customer states that the needle hub separated when the shield was removed.The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch# 9231296.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.There was one (1) notification noted for raised hubs.Root cause was unknown.Affected product was stated, contained, and destroyed.Capa1630423 has been opened to address this issue.

Event Description

It was reported that a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use, and a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle shield was hard to remove and one syringe that the needle hub separated when the shield was removed.Also, one syringe where the needle broke off into the consumer's stomach, but was able to remove the needle with tweezers.Verbatim: consumer reported found 5-6 syringes needle shield hard to remove consumer reported found 1 syringe shield hard to remove when removed the needle hub went with it.Lot #: 9231296.Catalog#: 928857.Date of event: (b)(6) 2021 needle hub removed with shield removal.Date of event unknown for the 5-6 syringes shields hard to remove.Samples status awaiting sample.Consumer reported 1 syringe when injected into stomach the needle broke off into stomach/site.She was able to remove with tweezers on her own.Denied reuse of needles.".

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11305412
• MDR Text Key: 251491720
• Report Number: 1920898-2021-00178
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1