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

Catalog Number	309579
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter: address unavailable.Bd corporate address used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd luer-lok¿ syringe was received damaged.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 309579, batch no.: 8329717.It was reported the product was received damaged.Verbatim: product is damaged/leaking/outdated.Please let us know if a call tag will be issued or if you would like us to destroy or donate the product.
Additional Manufacturer Narrative
Correction: this complaint is a service complaint and not a product complaint.Complaint to be cancelled as a product complaint.
Event or Problem Description
It was reported that bd luer-lok¿ syringe was received damaged.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 309579 batch no.: 8329717.It was reported the product was received damaged.Verbatim: product is damaged/leaking/outdated.Please let us know if a call tag will be issued or if you would like us to destroy or donate the product.

• Brand Name: BD LUER-LOK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8544383
• Report Number: 1213809-2019-00470
• Device Sequence Number: 16754914
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/31/2019

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: 11/30/2023
• Device Catalogue Number: 309579
• Device Lot Number: 8329717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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