MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120; PISTON SYRINGE

Catalog Number 303172

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 17 syringes 1ml ls sp120 had loose needle connectivity issues.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about syringe needle connectivity issue.The customer uses this product for covid vaccination.According to the customer's report, the connection between syringe and needle is loose and the needle is easily detached from the syringe.".

Manufacturer Narrative

H.6.Investigation: ten samples were provided to our quality team for investigation.The product was visually inspected, no damage, burrs, or other defects were observed within the tip of any of the syringes.A device history review was performed for the reported lot 2009096, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes visual and functional inspections throughout manufacturing, including verification of tip and thread dimensions.Testing results performed during manufacturing were reviewed lot 2009096 and all results were found to be within required limits.Ten retained samples of lot 2009096 were used for additional evaluation.The product was visually inspected, no defects or damage was observed on any of the product, including the syringe tips.Evaluations were performed on both the retained samples and product that was returned, verifying all tips were within required specifications, including the luer cone fitting.Leakage testing was also completed and all product was found to meet required limits.Based on the available information we are not able to determine a root cause related to the manufacturing process at this time.H3 other text : see h.10.

Event Description

It was reported that 17 syringes 1ml ls sp120 had loose needle connectivity issues.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about syringe needle connectivity issue.The customer uses this product for covid vaccination.According to the customer's report, the connection between syringe and needle is loose and the needle is easily detached from the syringe.".

• Brand Name: SYRINGE 1ML LS SP120
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12284822
• MDR Text Key: 265619627
• Report Number: 3003152976-2021-00454
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: 2009096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1