MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305064
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
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.
Event or Problem Description
Material no: 305064, batch no: 9205240.It was reported before use of the syr 10ml ll w/ndl 18x1-1/2 blunt fill the needle on syringe is loose and unable to tighten.The following information was provided by the initial reporter: per customer, 50% of them blunted needles were on the syringe loosely, but can be tighten manually (this required an additional ¼ turn to tighten) to be used.Out of the 50 % of the syringes that had issues: the other 50% of them the blunted needle were on the syringe loosely, but cannot be tighten manually, and cannot be used.
Event or Problem Description
Material no: 305064, batch no: 9205240.It was reported before use of the syr 10ml ll w/ndl 18x1-1/2 blunt fill the needle on syringe is loose and unable to tighten.The following information was provided by the initial reporter: per customer, 50% of them blunted needles were on the syringe loosely, but can be tighten manually (this required an additional ¼ turn to tighten) to be used.Out of the 50 % of the syringes that had issues: the other 50% of them the blunted needle were on the syringe loosely, but cannot be tighten manually, and cannot be used.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.No corrective actions recommended since samples/photos were not received to confirm the product defect.

• Brand Name: SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9151684
• Report Number: 1213809-2019-00997
• Device Sequence Number: 19457629
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 12/03/2019

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 305064
• Device Lot Number: 9205240
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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