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

Catalog Number 515003

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Material no: 515003, batch no: 1902103.It was reported that before use of the bd phaseal¿ injector luer lock n35 the facility is having problems with packaging.When they wipe with alcohol, the perforations fall apart and packaging is very wet.The following information was provided by the initial reporter: they were having problems with the new packaging.Specifically when they wipe it with alcohol the perforations fall apart and the packaging is very wet.

Event Description

Material no: 515003; batch no: 1902103.It was reported that before use of the bd phaseal¿ injector luer lock n35 the facility is having problems with packaging.When they wipe with alcohol, the perforations fall apart and packaging is very wet.The following information was provided by the initial reporter: they were having problems with the new packaging.Specifically when they wipe it with alcohol the perforations fall apart and the packaging is very wet.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1902103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The surface of the lacquer paper was wiped with alcohol then wiped dry.This action was repeated four times, allowing the product to sit for an hour in between each operation.After four hours, no issues or abnormalities were identified.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8772083
• MDR Text Key: 151016618
• Report Number: 3003152976-2019-00449
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 515003
• Device Lot Number: 1902103
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other