MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 20 ML SYRINGE; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd plastipak¿ 20 ml syringes experienced luer tip deformation.The following information was provided by the initial reporter: three bd plastipak 20ml syringes identified with the luer connection deformed.Unable to attach needle.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd plastipak¿ 20 ml syringes experienced luer tip deformation.The following information was provided by the initial reporter: three bd plastipak 20ml syringes identified with the luer connection deformed.Unable to attach needle.
Additional Manufacturer Narrative
Investigation summary: three samples were provided to our quality team for investigation.Through visual inspection, the tips are observed to be crushed in the same location and the packaging is noted to be damaged.A device history review was performed for reported lot 2205051, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.While we could not identify a direct issue, based on the sample evaluation it was determined this incident was likely related to a misalignment of the strips during the packaging process.As a result, the product was damaged when sealed and packaging was not properly sealed.H3 other text : see h10.

• Brand Name: BD PLASTIPAK¿ 20 ML SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15442516
• Report Number: 3003152976-2022-00423
• Device Sequence Number: 5582402
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 09/26/2022

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: 300613
• Device Lot Number: 2205051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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