MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Model Number	305500
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
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: na.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 syringe allergy 1ml w/ndl 28x1/2 rb plunger would not move while drawing.The following information was provided by the initial reporter: material no: 305500, batch no: 730251.It was reported that plungers would not move while drawing and others have blunt needles.
Additional Manufacturer Narrative
Device available for eval?: yes.D.10.Returned to manufacturer on: 6/22/2020.H.6.Investigation: customer returned (28) 1cc, 12.7mm 28g bd allergy syringes with an open poly bag from lot # 7302510.Customer states that plungers would not move while drawing and others have blunt needles.Only 5 out of 28 samples were retuned with a plunger rod.These samples were tested and all were able to draw and expel properly without any observed defects.All 28 samples were tested for point geometry, lube, and cannula od (specs: outer diameter for 28g: 0.0140¿-0.0145¿).All observations fall within specifications.As per manufacturing, ¿due to this batch being manufactured in 2007 no dhr files are available as retention is 7 years.¿ root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that syringe allergy 1ml w/ndl 28x1/2 rb plunger would not move while drawing.The following information was provided by the initial reporter: material no: 305500, batch no: 730251.It was reported that plungers would not move while drawing and others have blunt needles.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10209600
• Report Number: 1920898-2020-00763
• Device Sequence Number: 11549076
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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): 07/08/2020

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: Other
• Device Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: 7302510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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