MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA X 1/2IN; PISTON SYRINGE

Model Number	329407
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7016828.Medical device expiration date: n/a.Device manufacture date: 2017-04-20.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that two syringe 0.5ml 30ga x 1/2in experienced hub separation from the device during use.The following information was provided by the initial reporter: material no.329407, batch no.7016828, unknown.Verbatim: issue: consumer reported when he removes the needle shield needle stays inside the needle shield.Incident date- (b)(6) 2019, occurence - 1, item# 329407, lot# 7016828.Issue: consumer reported when he pulled the shield, off, needle remained inside the needle shield.Incident date-unknown, occurrence -1, item# 329407, lot# unknown.Consumer uses the new needle each time of his injection.Offered to send the replacement to the distributor.
Additional Manufacturer Narrative
H.6.Investigation: customer returned two (2) loose 30gx12.7mm, 0.5ml bd insulin syringes, and an open polybag from lot 7016828.Consumer reported when he removes the needle shield needle stays inside the needle shield.Both returned syringes were examined, and the following was observed: one syringe exhibiting needle-hub/shield separation; the barrel tip was broken.One syringe with no observed issues.A review of the device history record was completed for batch# 7016828.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200683343, 200683104] noted that did not pertain to the complaint.There was one (1) notification [200683338] noted for cracked hubs.Dhr, l2l dispatches, and notifications were looked at, nothing pertaining to this defect could be found.Root cause for this defect cannot be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that two syringe 0.5ml 30ga x 1/2in experienced hub separation from the device during use.The following information was provided by the initial reporter: material no.329407; batch no.7016828, unknown.Verbatim: issue: consumer reported when he removes the needle shield needle stays inside the needle shield.Incident date- (b)(6) 2019; occurence-1; item# 329407; lot# 7016828.Issue: consumer reported when he pulled the shield, off, needle remained inside the needle shield.Incident date-unknown; occurence-1; item# 329407; lot# unknown.Consumer uses the new needle each time of his injection.Offered to send the replacement to the distributor.

• Brand Name: SYRINGE 0.5ML 30GA X 1/2IN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9547136
• Report Number: 1920898-2019-01522
• Device Sequence Number: 3445614
• Product Code: FMF
• UDI-Device Identifier: 00382903294077
• UDI-Public: 00382903294077
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: Lay User/Patient
• Device Model Number: 329407
• Device Catalogue Number: 329407
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/04/2020
• 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