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

Model Number	328506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 broke at the cannula during use.The following was reported by the initial reporter, "it was reported that needle broke off of syringe in site.Verbatim: consumer reported found 2 syringes when removed from site needle broke off in site.Two different days.Pet owner able to remove from site with his fingers.Denied reuse of items.".
Event or Problem Description
It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 wal broke at the cannula during use.The following was reported by the initial reporter: "it was reported that needle broke off of syringe in site.Verbatim: consumer reported found 2 syringes when removed from site needle broke off in site.Two different days.Pet owner able to remove from site with his fingers.Denied reuse of items.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0013346.D.4.Medical device expiration date: h.4.Device manufacture date: 2020-02-19.D.4.Medical device lot #: 0139917.D.4.Medical device expiration date:.H.4.Device manufacture date: 2020-06-26.D10: device available for eval yes,.D10: returned to manufacturer on: 2020-12-04.H6: investigation summary customer returned six (6) 31gx8mm, 1ml insulin syringes (5 from an open polybag from lot 0139917, and 1 loose).Consumer reported found 2 syringes when removed from site needle broke off in site.The 1 syringe returned loose was examined, and it was observed that the syringe exhibited a broken cannula; the fractured cannula was also returned by the customer.Microscopic examination of this syringe revealed characteristics such as residual bends on the hub-end of the fractured cannula, and ovality (deformation from the normally circular cross section).When viewed together these are all indicators of bending/re-straightening mode of failure.The other 5 syringes were tested for point geometry, outer diameter and lube coverage.The following was observed (specs: outer diameter for 31g cannula: 0.0100¿- 0.0105¿): data: point outer diameter (in.) lube sample 1 good 0.0103 good; sample 2 good 0.0103 good; sample 3 good 0.0103 good; sample 4 good 0.0103 good; sample 5 good 0.0103 good.All 5 tested syringes tested within specification.No evidence of manufacturing defect was observed.A review of the device history record was completed for batch # 0139917.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted for this complaint.A review of the device history record was completed for batch# 0013346.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure.The possible root cause for this issue (cannula broken): user error.No evidence of manufacturing related issues were observed on the returned samples.Microscopic examination of the returned sample revealed characteristics such as residual bends on both ends of the fractured cannula, and ovality (deformation from the normally circular cross section).When viewed together these are all indicators of bending/re-straightening mode of failure.H3 other text : see h.10.

• 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: 10898748
• Report Number: 1920898-2020-01622
• Device Sequence Number: 19500931
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (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): 01/21/2021

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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1