MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE BD LUER-LOK¿ TIP BD ECLIPSE¿ NEEDLE; BLOOD GAS ANALYSIS SYRINGE

Catalog Number 364390

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

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 cap of the bd preset¿ syringe bd luer-lok¿ tip bd eclipse¿ needle was loose during use.There was no report of injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for loose end cap with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for loose end cap was not observed as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for loose end cap with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PRESET¿ SYRINGE BD LUER-LOK¿ TIP BD ECLIPSE¿ NEEDLE
• Type of Device: BLOOD GAS ANALYSIS SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7275222
• MDR Text Key: 100445411
• Report Number: 9617032-2018-00013
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K022426
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 364390
• Device Lot Number: 7173900
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other