MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515052

Device Problem Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2002101 medical device expiration date: 2021-01-31 device manufacture date: 2020-02-10 medical device lot #: unknown medical device expiration date: unknown device manufacture date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3 bd phaseal optima injectors (n35-o) experienced a damaged or open unit package/seal where sterility was compromised.The following information was provided by the initial reporter: material no: 515052 batch no: 2002101;unknown customer uses 70% ipa and (b)(6) bleach wipes to wipe down everything going into the anti-room and clean room.It was noticed that the packaging of the injectors started to flake off and left white specks onto the injector.

Manufacturer Narrative

The following fields were updated due to additional information: d10 device available for eval?: yes.D10 returned to manufacturer on: 11/30/2020.H6 investigation: two samples were provided to our quality team for investigation.Upon visual inspection, white particles can be observed on the surface of the injector hub of only one sample.It was noted the packaging was wrinkled.A device history review was performed for lot 2002101, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Fifteen retained samples of the same lot were used for additional evaluation.The product was inspected and no particles were observed on any of the injectors.Sterilization testing was reviewed and results were found to be within specification.Through our investigation the particles were identified to consist of tyvek paper which is used in the packaging of this product.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.A review of manufacturing records established that all cleaning for the packaging lines were performed according to procedure.

Event Description

It was reported that 3 bd phaseal optima injectors (n35-o) experienced a damaged or open unit package/seal where sterility was compromised.The following information was provided by the initial reporter: material no: 515052; batch no: 2002101;unknown.Customer uses 70% ipa and clorox bleach wipes to wipe down everything going into the anti-room and clean room.It was noticed that the packaging of the injectors started to flake off and left white specks onto the injector.

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10849057
• MDR Text Key: 223616589
• Report Number: 3002682307-2020-00348
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515052
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1