MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; ADMINISTRATION SET

Catalog Number 515111

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

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 during use, a bd phaseal¿ protector p50j malfunctioned as the needle separated.They ¿disconnected the n35j and the p50j, but the needle of p50j remained in the rubber stopper of the vial.¿ there was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: the sample was evaluated at (b)(6).Based on the report received (28/feb/2018), it is confirmed that the needle is detached and found inclined in the rubber stopper of vial.No anomalies were found in the housing nor in the needle.However, there was a plastic protection which avoided the properly fitting of the protector to the vial.Inspections and tests: -during molding process, housing is reviewed according to (b)(6) (current version).It is verified the absence of burs, dirty and the properly measures of the needle housing (go/no go gauge).-during assembly process, the operator performs the visual inspection of the protector according to (b)(4) (current version).The cannula is checked: it is verified that is properly centered, oriented and properly assembled.It is also verified that it has not any type of damage (nicks).-during all the tests performed according to (b)(4) (overpressure test, leakage test, etc) the absence and/or fall of the cannula would be noticed.-the machine (p3) has several automatic controls which check the presence (station 21), length (station 22) and properly position (station 23) of the cannula.-if one of the stations detect any problem related to the cannula (absence, incorrect length, wrong position), the piece is thrown away (scrap) and do not continue the normal process.Conclusion: taking account the description of the complaint and the conclusions of (b)(6), the most likely root cause of the defect is bad handling of the device.The plastic protection avoid the properly fitting of the protector, therefore if it is not properly attached to the vial is easy to be removed.As protector is one single use, during manufacturing process no tests are performed to check that the cannula keep attached to the housing.Device history records of lot #1702026 have been checked and no qn's or other events were found.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7245471
• MDR Text Key: 99329946
• Report Number: 3003152976-2018-00016
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 515111
• Device Lot Number: 1702026
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other