MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P21); PHASEAL INJECTOR

Catalog Number 515102

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

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 a bd phaseal¿ protector (p21) was found with foreign matter during use.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: 1 unsealed and unused sample was received.(the sample was received without the individual packed).It was found a red residue inside the expansion chamber.The pictures show the residue as well.Also the individual pack with the lot information is shown in the pictures.Phaseal products are manufactured according to iso 13485 requirements in a class 8 clean area (iso 14644-1).Internal procedures describes the rules and instructions to enter the area.Clearance and cleaning of the assembly machine is performed according to internal procedures before starting a new lot.Maintenance of the assembly machines is performed in a weekly basis.During manufacturing process, visual inspection of the product is performed in order to avoid defects.The particle found in the protector is tough to be a part of o-rings used in the assembly machine.The appearance and the color of the o-ring match with the appearance and the color of the fm in the protector.These o-rings were not changed in a regular basis.Investigation conclusion: foreign matter- o-ring; 1 unsealed and unused sample was received on 24/nov/2017.(the sample was received without the individual packed).It was found a red residue inside the expansion chamber.The pictures show the residue as well.Also the individual pack with the lot information is shown in the pictures.Phaseal products are manufactured according to iso 13485 requirements in a class 8 clean area (iso 14644-1).Internal procedure ha-015 describes all the rules and instructions to follow before entering the phaseal area: wash and dry the hands, no make-up and jewelry allowed, special clothes and clean room gown are dressed in the area, clean room shoes, etc.Other measurements were implemented in the area for avoid fm: new equipment (flow cabinet for visual inspections/re-process) and machines encapsulation have been installed in phaseal assembly and molding area.The brushes for cleaning have been changed for others that not loose fibers.Clearance and cleaning of the assembly machine is performed according to ph-006 and ph-007, before starting a new lot.Maintenance of the assembly machines is performed in a weekly basis.Inspections in manufacturing area: visual inspection is performed in molding area to detect flashes, bubbles, unfilled, burnt, incorrect color, particles and f.M (plastic particles, metallic fragments, fibers, hairs, grease and oil).This is performed according to procedure ph-300 (current version).During assembly process, the operator performs the following inspections and tests according to ph-302 (current version).During packaging process of phaseal product, 100% visual inspection of the product is performed by the operator according to ph-009.During the visual inspection: product is verified to avoid quality defects (contamination, damages, assembly failures and correct forming and sealing of the packages).Root cause description: the particle found in the protector is tough to be a part of o-rings used in the p3 assembly machine, station #12.The appearance and the color of the o-ring match with the appearance and the color of the fm in the protector.These o-rings were not changed in a regular basis.

• Brand Name: BD PHASEAL¿ PROTECTOR (P21)
• Type of Device: PHASEAL 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: 7060583
• MDR Text Key: 93732848
• Report Number: 3003152976-2017-00113
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 02/28/2022
• Device Catalogue Number: 515102
• Device Lot Number: 1703121
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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