MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 23X1 RB; PISTON SYRINGE

Catalog Number	309571
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
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
It was reported that the syringe 3ml ll w/ndl 23x1 rb experienced cracking and leakage.The following information was provided by the initial reporter: material no.: 309571, batch no.: 9056847.It was reported one syringe cracked and leaked.
Additional Manufacturer Narrative
Investigation: one 3ml syringe in an opened blister pack from batch #9056847 (p/n 309571) was received and evaluated.It was observed there was a lengthwise crack in the barrel extending from the 1/2ml to the 1 1/2ml marking.There were also some dried white fluid droplets present on the inside and outside of the barrel and on the plunger rod.Furthermore, 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.Potential root cause for the damaged barrel defect is associated with the assembly process.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl 23x1 rb experienced cracking and leakage.The following information was provided by the initial reporter: material no.: 309571 batch no.: 9056847.It was reported one syringe cracked and leaked.

• Brand Name: SYRINGE 3ML LL W/NDL 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8593414
• Report Number: 1213809-2019-00518
• Device Sequence Number: 2192920
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/11/2019

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: 01/31/2024
• Device Catalogue Number: 309571
• Device Lot Number: 9056847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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