MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK (N35C); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515005

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that the bd phaseal¿ injector luer lock (n35c) caused "repetitive strain" to the pharmacy worker's forearm as a result of the "push turn push motion" of the device connection, and assessment from occupational health was sought out with recommendations that the worker be removed from the compounding shifts.The following information was provided by the initial reporter: "hi (b)(6), we have had some pharmacy technician staff come forward recently with repetitive strain related pain in their dominant forearm as a result of the push turn push motion of phaseal device connections.They are seeking assessment from occupational health as a result and there may be recommendations to have them removed from the compounding shifts which is concerning.Can you comment if this is occurring at other sites and if you have any strategies in terms of manipulation techniques to help to prevent/mitigate this? much appreciated, (b)(6)".

Manufacturer Narrative

Correction: b.5.Describe event or problem: it was reported that the bd phaseal¿ injector luer lock (n35c) caused "repetitive strain" to the pharmacy worker's forearm as a result of the "push turn push motion" of the device connection, and assessment from occupational health was sought out with recommendations that the worker be removed from the compounding shifts.The following information was provided by the initial reporter: we have had some pharmacy technician staff come forward recently with repetitive strain related pain in their dominant forearm as a result of the push turn push motion of phaseal device connections.They are seeking assessment from occupational health as a result and there may be recommendations to have them removed from the compounding shifts which is concerning.Can you comment if this is occurring at other sites and if you have any strategies in terms of manipulation techniques to help to prevent/mitigate this? h.6.Investigation summary: no pictures or samples are available for investigation.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples could not be investigated.Inspections and tests: several test and inspections are performed during the manufacturing of the devices to ensure their quality.During molding process (according ph-300) visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc).Also, critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance.During assembly process visual inspection is performed (according to ph-301) to ensure the proper assemble of the pieces.Functionality test also takes place.

Event Description

It was reported that the bd phaseal¿ injector luer lock (n35c) caused "repetitive strain" to the pharmacy worker's forearm as a result of the "push turn push motion" of the device connection, and assessment from occupational health was sought out with recommendations that the worker be removed from the compounding shifts.The following information was provided by the initial reporter: we have had some pharmacy technician staff come forward recently with repetitive strain related pain in their dominant forearm as a result of the push turn push motion of phaseal device connections.They are seeking assessment from occupational health as a result and there may be recommendations to have them removed from the compounding shifts which is concerning.Can you comment if this is occurring at other sites and if you have any strategies in terms of manipulation techniques to help to prevent/mitigate this?.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK (N35C)
• 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: 8433735
• MDR Text Key: 139245542
• Report Number: 3003152976-2019-00211
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• Combination Product (y/n): N
• PMA/PMN Number: K140591
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention