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

Catalog Number 364390

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter fax#: (b)(6).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 before use of the bd preset¿ syringe with bd luer-lok¿ tip.Bd eclipse¿ needle the ¿nurse opened the abg package, due to no cannula cap, the nurses hand was stuck by the needle, blood leaked.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for missing iv shield with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, all samples contained the iv shield.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 photos, the customer¿s indicated failure mode for missing iv shield with the incident lot was observed.Additionally, evaluation of the retain samples was conducted and missing iv shields were not observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.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 WITH 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: 7331795
• MDR Text Key: 102325391
• Report Number: 9617032-2018-00046
• 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,health professional,o
• 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: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 364390
• Device Lot Number: 7111789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other