MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR N35-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515052

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

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2002106, medical device expiration date: 2021-01-31, device manufacture date: 2020-02-13.Medical device lot #: 2001104, medical device expiration date: 2020-12-31, device manufacture date: 2020-01-20.Medical device lot #: 2002111, medical device expiration date: 2021-01-31, device manufacture date: 2020-02-27.Medical device lot #: 2001102, medical device expiration date: 2020-12-31, device manufacture date: 2020-01-17.Medical device lot #: 1912105, medical device expiration date: 2020-11-30, device manufacture date: 2019-12-13.Medical device lot #: 2002108, medical device expiration date: 2021-01-31, device manufacture date: 2020-02-18.Medical device lot #: 1912106, medical device expiration date: 2020-11-30, device manufacture date: 2019-12-16.Medical device lot #: 2002102, medical device expiration date: 2021-01-31, device manufacture date: 2020-02-10.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that an unspecified number of injector n35-o had foreign matter before use.The following was reported by the initial reporter: "it was reported there was a white powder on the injector."while setting up supplies to prepare a chemo dose, a tech at (b)(6) pharmacy found a phaseal injector (n35-o) with white powder.Lot # 2003103, expiration date: 2021-02-28, manufacture date: 2020-03-01.The tech had opened the package and noticed the powder around injector.Issue was immediately reported to me.Tech and i removed all items with same lot # from iv room and supply room.Incident was immediately reported to my pharmacy manager and shared at (b)(6).I also sent communication to (b)(6) nursing, mms group and main campus pharmacy leadership, and pharmacy quality and regulatory leaders." (b)(6) provided labels to rep.Tracking listed below.05jan2020: several lot codes returned by customer.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-10.H6: investigation summary : multiple cases of injector samples were provided to our quality team for investigation.Upon inspecting the product, white particles can be observed on the surface of the injectors.A device history review was performed for lots 1912105, 1912106, 2001102, 2001104, 2002106,2002108, 2002111, 2002102, and 2001111, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Fifteen retained samples of each of the reported lots were used for additional evaluation.The product was inspected and particles could only be observed on some of the injectors when using magnification.Sterilization testing was performed and results were found to be within specification.The product was sent for characterization testing and 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.H3 other text : see h10.

Event Description

It was reported that an unspecified number of injector n35-o had foreign matter before use.The following was reported by the initial reporter: "it was reported there was a white powder on the injector."while setting up supplies to prepare a chemo dose, a tech at woodlands pharmacy found a phaseal injector (n35-o) with white powder.Lot # 2003103.Expiration date: 2021-02-28.Manufacture date: 2020-03-01.The tech had opened the package and noticed the powder around injector.Issue was immediately reported to me.Tech and i removed all items with same lot # from iv room and supply room.Incident was immediately reported to my pharmacy manager and shared at trb.I also sent communication to woodlands nursing, mms group and main campus pharmacy leadership, and pharmacy quality and regulatory leaders." dchu provided labels to rep.Tracking listed below.Communications attached.05jan2020: several lot codes returned by customer.".

• Brand Name: INJECTOR N35-O
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11131274
• MDR Text Key: 242879642
• Report Number: 3003152976-2021-00009
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515052
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1