MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA; 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	06/27/2019
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.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.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Event or Problem Description
It was reported that a needle break occurred during use with a syringe 1.0 ml 28ga 1/2 in bls 500 sus ca.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.300 cases.105 cases.Item #329420 lot and expiration: lot #8337907 expiration is 2-29-2024, lot #7079902 expiration is 4-30-2022, lot #8183955 expiration is 9-30-2023, lot #8169595 expiration is 9-30-2023.".

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8925456
• Report Number: 1920898-2019-00861
• Device Sequence Number: 2129261
• 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): 08/08/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/23/2019
• 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