MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Catalog Number	305946
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Material no.305946, batch no.Unknown.It was reported that during use of the syringe sftygld 1ml w/ndl 26x3/8 ib the syringe plunger would not depress.Medication can be pulled up, but can¿t be administered.The plunger will not move.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: med pulled up fine into the syringe, but can¿t be administered; plunger won¿t budge.
Event or Problem Description
Material no.305946 batch no.Unknown.It was reported that during use of the syringe sftygld 1ml w/ndl 26x3/8 ib the syringe plunger would not depress.Medication can be pulled up, but can¿t be administered.The plunger will not move.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: med pulled up fine into the syringe, but can¿t be administered; plunger won¿t budge.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) loose 1cc safetyglide syringe without any packaging.Customer states that the plunger won¿t budge.The returned syringe was tested and the plunger was able to be exercised in the barrel without any observed defects.A dhr check was not performed as the lot number is "unknown" for this complaint.The complaint is unconfirmed and the root cause could not be determined.

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8778522
• Report Number: 1920898-2019-00644
• Device Sequence Number: 11285650
• Product Code: MEG
• UDI-Device Identifier: 30382903059462
• UDI-Public: 30382903059462
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 305946
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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