MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿INFUSSIONSYSTEME ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515303

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Initial reporter phone: (b)(6).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 the after filling the bd phaseal¿ infussion systeme adaptor (c70) with the saline infusion bag and active ingredient, the product was connected and packaged in a sterile bag for transport from the clean room laboratory.During removal from the clean room, it was found that the bd phaseal c70 has split into two parts.The infusion solution with the drug / antibody leaked inside the protective bag.Our customer has been working with bd phaseal for years and is absolutely familiar with the product.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: customer complaint about the breakage and leak in the device.Some pictures are available, but the defect is not easily seen.The sample was sent directly to codan for investigation.The only manufacturing processes related to infusion adapter c70 in s.Agustin plant are the connector molding and membrane assembly.The rest of components of the set (plastic tubes, clamp, etc) are performed by codan supplier and final assembly is performed by codan as well.Based on the report received by codan, the root cause of the defect is considered an overstressing of the tube due to the handling of the device.Manufacturing inspections: the only manufacturing processes of infusion adapter c70 in s.Agustin plant are the connector molding and membrane assembly.The rest of components of the set (plastic tubes, clamp, etc) are performed by codan supplier and final assembly is performed by codan as well.A device history record review found no non-conformances associated with this issue during production of this batch and upon checking all relevant files and documents of the production process of this spike we could not find any indication that would lead to a processing- or material defect.These are the inspections performed by the supplier according to sb1745 current version: codan carefully examined the broken spike showed that it broke at its base, directly at the main body section of the component.The surface of the area showed no indication for a defect of the material or of the moulding process.Main cause: the cause of this broken spike is quite likely an overstressing during transportation from the laboratory to the ward.Although we don¿t know details about the transportation it is possible that an inadvertant and accidental hard push could have created strong forces on the spike, especially as it was connected to a heavier infusion bag.Documentation: upon checking all relevant files and documents of the production process of this spike we could not find any indication that would lead to a processing- or material defect.Evaluation: we can¿t see a mistake of our production at any time in the whole procedure.The crack was not caused by a material defect but through overstressing during transportation from the preparation area to the ward.Investigation conclusion: the sample evaluated by codan confirms the claimed defect.However, it seems that the defect was not caused during manufacturing process but during its use at the hospital.

• Brand Name: BD PHASEAL¿INFUSSIONSYSTEME ADAPTOR
• 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: 7342188
• MDR Text Key: 102715804
• Report Number: 3003152976-2018-00100
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other