MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P21J; PHASEAL ADMINSTRATION SET

Catalog Number 515110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Batch number [1805131] was not found for material number [(b)(4)] so the manufacture and expiration dates are unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd phaseal¿ protector p21j there was an issue with the needle detaching and stung to the vial when the protector was engaged.

Manufacturer Narrative

H.6.Investigation summary: needle separation on protector the sample was evaluated by jfr lab.According to the report, no defect was found in the needle.No defect found in needle housing.The needle was found separated from the protector.Inspections and tests in manufacturing area for protectors: during molding process, housing is reviewed according to ph-300 (current version).It is verified the absence of burs, dirty and the properly measures of the needle housing (pass/fail).During assembly process, the operator performs the visual inspection of the protector according to ph-302 (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 ph-302 (overpressure test, leakage test, etc) the absence or fall of the cannula would be noticed.The assembly 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 detects any problem related to the cannula (absence, incorrect length, wrong position-cannula bent), the piece is thrown away (scrap) and do not continue the normal process.Please note, the lot code reported(1805131) corresponds to product item # 515111 which is different than the product code reported (515110).A device history review was performed for reported lot code 1805131 and identified no non-conformances related to this issue during the production if the reported batch.No maintenance interventions related to the cannula assembly stations were found during dhr review.The root cause cannot be clearly establish.Please take into account that protectors are not intended to be removed once they are attached.If the connection was not properly done at first time and there was a second correction later, the protector can be detached.

Event Description

It was reported with the use of the bd phaseal¿ protector p21j there was an issue with the needle detaching and stung to the vial when the protector was engaged.

• Brand Name: BD PHASEAL¿ PROTECTOR P21J
• Type of Device: PHASEAL ADMINSTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8348271
• MDR Text Key: 136865289
• Report Number: 3003152976-2019-00157
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515110
• Device Lot Number: 1805131
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other