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

Catalog Number 303172

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/29/2021

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 the syringe 1ml ls sp120 was difficult to connect to the tfk laboratory needle.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." "the connection of this syringe (cat#303172) to tsk laboratory¿s needle became loose in 20 of 320 products.".

Manufacturer Narrative

H.6.Investigation: twenty two samples and photos received for investigation, upon visual inspection of the samples received, no molding or other defect can be noticed in the syringe, no burrs or deformations can be seen in the tip.Additionally, ten retained samples of lot 200612 were used to conduct a leakage test.The product was visually inspected, no defects or damage was noted, and no leak was identified.A device history review was performed for lot 2006012, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information we are not able to determine a root cause at this time.

Event Description

It was reported that the syringe 1ml ls sp120 was difficult to connect to the tfk laboratory needle.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." "the connection of this syringe (cat#303172) to tsk laboratory¿s needle became loose in 20 of 320 products.".

• 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: 12242750
• MDR Text Key: 264726590
• Report Number: 3003152976-2021-00432
• 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: 09/13/2021

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
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: 2006012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1