MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100J; ADMINISTRATION SET

Catalog Number 515310

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported after preparing endoxan (chemotherapy medication) using a bd phaseal¿ infusion adapter c100j and connecting with nipro infusion bag; leakage occurred from the connection.Skin exposure occurred to the health care professional.There was no medical intervention reported.

Manufacturer Narrative

Investigation summary: the customer complaints about the leakage in c100 infusion adapter.The sample has been evaluated by (b)(4).According to its report no leak has been confirmed: no leak found when the infusion bag was pressurized, no leak found when the drug flowed through the infusion set.No anomalies were found inside the connection port and no defects were found in spike needle.During assembly process, visual inspection of infusion adapter is performed.Visual inspection also takes place during packing and packaging process to avoid faulty items.In this case, as the lot is unknown device history record cannot be reviewed.The customer complaints about the leakage in c100 infusion adapter.The sample has been evaluated by (b)(4).According to its report (received on 28/feb/2018) no leak has been confirmed: no leak found when the infusion bag was pressurized, no leak found when the drug flew through the infusion set.No anomalies were found inside the connection port and no defects were found in spike needle.Inspections in manufacturing area: all components of connector c100, except the membrane, are molded in (b)(4) supplier.After molding, the components are assembled in (b)(4) plant.During assembly process, the operator performs visual inspection of the membrane, spike port, housing and cap to verify that product is free of damages (procedure (b)(4)).The operator takes 24 samples for each 1.000 units and verified the welding of the membrane, correct assembly and quality of the components.During the packaging process of phaseal product, visual inspection of the product is performed by the operator according to (b)(4).Eight samples are taken for visual inspections (2 strips) to verify the quality of the blisters.On the other hand, 100% visual inspection is performed for all phaseal product by the operator before place the product in the unit case.During the load of product in the unit cases, the operator checks the correct quality of the product (free of damages, f.M).In case of faulty product, it is sent to scrap.In case of packaging defects, samples are picked up and packaged again.Leakage test is performed in all lots according to (b)(4).Conclusion the leak cannot be confirmed.As the lot is unknown, dhr cannot be reviewed.

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100J
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7300444
• MDR Text Key: 101083599
• Report Number: 3003152976-2018-00052
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K110023
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515310
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other