MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G; PISTON SYRINGE

Catalog Number	309580
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 while using bd luer-lok¿ syringe with attached needle 18 g foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer there was a rubber on the needle of a syringe that was inserted into a vial.There was a rubber on the needle of a syringe that was inserted into a vial.I noticed the rubber on the needle when i was extracting the product, and when i pulled out the needle the rubber remained in the vial.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 21-jun-2022.H6: investigation summary: one sample and three photos were provided to our quality team for investigation.Through visual inspection foreign matter was not observed on the sample received.The reported defect was not identified in the physical samples received, therefore corrective actions are not necessary.A device history record review was completed for provided lot number 1350219.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 18 g foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer there was a rubber on the needle of a syringe that was inserted into a vial.There was a rubber on the needle of a syringe that was inserted into a vial.I noticed the rubber on the needle when i was extracting the product, and when i pulled out the needle the rubber remained in the vial.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14651826
• Report Number: 1213809-2022-00328
• Device Sequence Number: 4918812
• Product Code: FMF
• UDI-Device Identifier: 00382903095803
• UDI-Public: 00382903095803
• 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
• Serviced by Third Party (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): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309580
• Device Lot Number: 1350219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown