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
Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a difficult plunger occurred during use with a syringe sftygld 1 ml w/ndl 26 x 3/8 ib.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.We tested total of 50 syringes from the 3 lots we have and all were fine.2 occurrences were reported date/time and patient information were not given.1 of 2 complaints.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) loose 1ml, bd safetyglide syringe filled with approximately 0.35ml of a clear liquid in the barrel with a label that states that the medication is enoxaparin.Customer states that the plunger would not depress.The returned syringe was tested and the plunger was not able to depress.This is most likely due to crystallized medication in the cannula that is preventing the liquid in the barrel to be expelled.A dhr was not performed as the lot number is "unknown" for this complaint.This is most likely due to crystallized medication in the cannula as the syringe was able to draw properly, as per the customer.H3 other text : see h.10.
Event or Problem Description
It was reported that a difficult plunger occurred during use with a syringe sftygld 1ml w/ndl 26x3/8 ib.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.We tested total of 50 syringes from the 3 lots we have and all were fine.2 occurrences were reported date/time and patient information were not given.1 of 2 complaints.

• 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: 8833855
• Report Number: 1920898-2019-00708
• Device Sequence Number: 11448684
• 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): 08/16/2019

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: 07/26/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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