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

Model Number	309578
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd luer-lok¿ syringe was damaged, causing leakage.The following information was provided by the initial reporter: "we recently found trouble with a specific lot of syringes.Where the syringes have a crack in them.This is dangerous, as we found when a crack in a syringe caused some medication to spray out.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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 bd luer-lok¿ syringe was damaged, causing leakage.The following information was provided by the initial reporter: "we recently found trouble with a specific lot of syringes.Where the syringes have a crack in them.This is dangerous, as we found when a crack in a syringe caused some medication to spray out.".
Event or Problem Description
It was reported bd luer-lok¿ syringe was damaged, causing leakage.The following information was provided by the initial reporter: "we recently found trouble with a specific lot of syringes.Where the syringes have a crack in them.This is dangerous, as we found when a crack in a syringe caused some medication to spray out.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-08.D4: medical device lot #: 1076679.D4: medical device expiration date: 2026-02-28.H4: device manufacture date: 2021-03-17.D4: medical device lot #: 6062957.D4: medical device expiration date: 2021-02-28.H4: device manufacture date: 2016-03-02.Investigation summary: thirty-two 3ml syringes (p/n 309578) sealed in their blister packages were received.The samples were visually evaluated.Twenty-eight samples were from batch #0122568, two were from batch #1076679, and two were from batch #6062957.The samples were found to have no cracks or visible defects present.Batch #6062957 was expired as of february 2021 and bd does not make claims about the performance or efficacy of expired products.Since the samples received did not display the reported condition a potential root cause could not be defined, and corrective actions are not necessary.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.H3 other text : see h10.

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12857501
• Report Number: 1213809-2021-00778
• Device Sequence Number: 5095155
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 309578
• Device Catalogue Number: 309578
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/19/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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