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

Model Number	328506
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11234207
• Report Number: 1920898-2021-00115
• Device Sequence Number: 14545803
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1