MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE IV INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	329420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8337907.Medical device expiration date: 2024-02-29.Device manufacture date: 2018-12-03.Medical device lot #: 7079902.Medical device expiration date: 2022-04-30.Device manufacture date: 2017-03-20.Medical device lot #: 8183955.Medical device expiration date: 2024-02-29.Device manufacture date: 2018-12-03.Medical device lot #: 8169595.Medical device expiration date: 2023-09-30.Device manufacture date: 2018-06-18.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 8337907.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description : root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
Material no.329420, batch no.8337907,7079902,8183955,8169595.It was reported that during use of the bd micro-fine¿ iv insulin syringe the needles are breaking.The distributor provided four different lot numbers: 8337907, 7079902, 8183955, and 8169595.Customer provided three dates: this complaint captures (b)(6) 2019.The following information was provided by the initial reporter: customer is stating they no longer can use and also that the needles are breaking.I don't know if they reported the issue but they won't use and we don't have any other customers that use this product.

• Brand Name: BD MICRO-FINE IV INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8921800
• Report Number: 1920898-2019-00859
• Device Sequence Number: 2048867
• Product Code: FMF
• UDI-Device Identifier: 30382903294207
• UDI-Public: 30382903294207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 329420
• Device Lot Number: SEE H.10
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other