MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL; PISTON SYRINGE

Model Number 328506

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

"medical device expiration date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).".

Event Description

It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 wal leaked, and broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle broke off in the consumer's injection site.Also.Insulin leaked from the injection site during the injection.Verbatim: consumer reported that the needle broke off in her injection site.Consumer attempted to remove the needle with a tweezer but was unsuccessful.U{date per snow: consumer reported that the needle broke off in her injection site.Consumer attempted to remove the needle with a tweezer but was unsuccessful.Consumer did not seek medical attention.Consumer also stated that the insulin leaked from the injection site during injection.Consumer does not re-use.".

Event Description

It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 wal leaked, and broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle broke off in the consumer's injection site.Also.Insulin leaked from the injection site during the injection.Verbatim: consumer reported that the needle broke off in her injection site.Consumer attempted to remove the needle with a tweezer but was unsuccessful.U{date per snow: consumer reported that the needle broke off in her injection site.Consumer attempted to remove the needle with a tweezer but was unsuccessful.Consumer did not seek medical attention.Consumer also stated that the insulin leaked from the injection site during injection.Consumer does not re-use.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-04-30.H6: investigation summary: customer returned (1) loose 1cc, 8mm, 31g relion syringe with the shelf carton from lot # 0168501.Customer states that insulin leaked from the injection site during the injection.The returned syringe was examined and exhibited a broken cannula.Customer states that the needle broke off in the consumer's injection site.The returned syringe was examined and exhibited a broken cannula.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.The shield was also examined for any possible scrapes or cuts related by cannula recapping or improper shielding, however nothing was observed.The broken cannula could also cause insulin to leak at the injection site during the injection.A review of the device history record was completed for batch #0168501.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause is user related.The cannula broke by bending/re-straightening mode of failure during use of the product by the customer.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11234207
• MDR Text Key: 230097530
• Report Number: 1920898-2021-00115
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• 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: 04/21/2021

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: Lay User/Patient
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 0168501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1