MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number	301997
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 bd luer-lok¿ tip syringe plunger and barrel were damaged.
Additional Manufacturer Narrative
Investigation summary: five photos and one 10ml syringe from unknown batch# were received and evaluated.The syringe was crushed with severe damage to the barrel observed in several areas including the flange, the wall and luer area as well as the plunger rod.The most damaged location appeared to be the mid portion of the barrel around the 8ml markings.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Root cause for the barrel damaged defect is likely associated with the assembly process.The batch # is unknown, therefore defective rate cannot be identified.Batch # is required to determine if corrective actions are necessary.No corrective actions will be taken based on the available information.
Event or Problem Description
It was reported that the bd luer-lok¿ tip syringe plunger and barrel were damaged.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8175080
• Report Number: 1213809-2018-00902
• Device Sequence Number: 1620364
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 301997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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