MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that liquid was found in the bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: one nurse had the impression of seeing a scratch in the body of the syringe and on closer examination the presence of a liquid in the syringe; liquid that came out of the syringe after pushing on the plunger.
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
H.6.Investigation: no photos or physical samples that display the reported condition have been provided for evaluation.A device history review was performed for reported lot 2202042, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 2202042 were used for additional evaluation.The products were visually inspected, no lubricant or other liquid was observed inside any of the syringes.
Event or Problem Description
It was reported that liquid was found in the bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter, translated from french to english: one nurse had the impression of seeing a scratch in the body of the syringe and on closer examination the presence of a liquid in the syringe; liquid that came out of the syringe after pushing on the plunger.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14492625
• Report Number: 3002682307-2022-00145
• Device Sequence Number: 17601527
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: Health Professional
• Device Catalogue Number: 300613
• Device Lot Number: 2202042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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