MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; FLUID TRANSFER IV SET

Catalog Number 515105

Device Problems Leak/Splash (1354); Fitting Problem (2183)

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

Event Date 11/22/2017

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 vial adapter on a bd phaseal" protector p50 did not fit tightly onto the vial neck which tends to easily disconnect and cause drug leakage.There was no report of injury or medical intervention.

Manufacturer Narrative

No pictures or samples were received to verify that the vial adapter does not fit tightly to vial neck.Upon visual inspection of retained samples, the protector properly fits the vial and no leak occurred.A device history record review found no non-conformances associated with this issue during production of this batch.Protector housing were manufactured by (b)(4).Currently, they are molded in bd (b)(4).During manufacturing process, several tests and inspections are carried out to avoid faulty parts.During molding process visual inspection is performed.Critical to quality, dimensions are measured: protector highness is verified at the beginning of the lot, after a long machine stop and after a molding repair.During the assembly process, functionality of the protector is performed.Conclusion: without a sample and based on the investigation on the retained sample and device history record review, the root cause of this incident cannot be determined.In order to obtain the best results with phaseal devices, it is recommended to carefully follow the instructions explained in the ifu.The p50 protector is intended to be used with 20 mm neck vials.Based on the low severity and frequency of the defect and acceptable results for retained samples and manufacturing process, it was determined that no capa is required.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• Type of Device: FLUID TRANSFER IV SET
• 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: 7173488
• MDR Text Key: 96846596
• Report Number: 3003152976-2017-00232
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 515105
• Device Lot Number: 1604033
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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