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	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.The following lot numbers were provided by the distributor, but the actual lot is unknown.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: 2023-09-30.Device manufacture date: 2018-07-02.Medical device lot #: 8169595.Medical device expiration date: 2023-09-30.Device manufacture date: 2018-06-18.
Event or Problem Description
Material no.329420, batch no.Unknown (provided 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, but the actual lot number is unknown.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.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A review of the device history record was completed for batch# 7079902.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200694158] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 8183955.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 8169595.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
Event or Problem Description
Material no.329420 batch no.Unknown (provided 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, but the actual lot number is unknown.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: 8859268
• Report Number: 1920898-2019-00757
• Device Sequence Number: 11292544
• 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,Followup
• Report Date (Section B): 08/20/2019

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
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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