MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYR 10ML LL W/NDL SFTYGLD 22X1-1/2 RB; PISTON SYRINGE

Model Number	305908
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a syr 10ml ll w/ndl sftygld 22x1-1/2 rb had a loose stopper during use.The following was reported by the initial reporter: "suspected needle core rubber plug slipping".
Event or Problem Description
It was reported that a syr 10ml ll w/ndl sftygld 22x1-1/2 rb had a loose stopper during use.The following was reported by the initial reporter: "suspected needle core rubber plug slipping".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval? yes.D.10.Returned to manufacturer on: 1/29/2021.H.6.Investigation: one sample was provided for investigation.During investigation the customer complaint was able to be confirmed.Separation of the stopper was seen when an inappropriate.Syringe needle was used with the product.A device history record review was completed by our quality engineer team for provided lot number: 9064838.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The root cause was determined to be user error.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of suspected needle core rubber plug slipping with lot#: 9064838 regarding item#: 305908.

• Brand Name: SYR 10ML LL W/NDL SFTYGLD 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11276047
• Report Number: 1920898-2021-00145
• Device Sequence Number: 3440791
• Product Code: MEG
• UDI-Device Identifier: 30382903059080
• UDI-Public: 30382903059080
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 305908
• Device Catalogue Number: 305908
• Device Lot Number: 9064838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1