MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35

Catalog Number 515001

Device Problem Leak/Splash (1354)

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

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(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 that leaking was found from a bd phaseal¿ injector luer lock n30c.The bd phaseal¿ injector luer lock n30c was pulled out, after the drug was transferred into the iv bag, leaving the needle left unprotected.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: bd received four photographs from the customer facility for investigation.The pictures showed the needle exposed.This takes place as the injector is still active while disconnection.The grips are out of place.Additionally, two retention samples were selected for evaluation, and the customer's indicated failure mode for leakage and broken safety shield was not observed as all samples met specifications.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.The root cause is considered a misuse of the defect.

Manufacturer Narrative

Date of event and received by manufacturer corrections.The date of event and date received by manufacturer fields have been updated to reflect the corrected dates as indicated below: date of event: (b)(6) 2017.Date received by manufacturer: 11/22/2017.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Type of Device: INJECTOR
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7122579
• MDR Text Key: 95078330
• Report Number: 3003152976-2017-00196
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150013
• UDI-Public: 30382905150013
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 515001
• Device Lot Number: 1706106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other