MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD INFUSION ADAPTER C100 WITH BUILT-IN PHASEAL¿ CONNECTOR; ADMINISTRATION SET

Catalog Number 515306

Device Problems Device Slipped (1584); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation: a sample is available for evaluation but has not been received.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the bd infusion adapter c100 with built-in phaseal (tm) connector was inserted into a baxter infusion bag, decitabine was injected, and the entire bag with the bd phaseal (tm) device was refrigerated to maintain the stability of the drug.When it was sent to nursing to set up the infusion, the bd phaseal (tm) adapter slid out of the bag, and the contents of the bag were spilled onto the patient, family member, and staff member.The staff member was seen by employee health but no treatment was given.The staff member scrubbed the area of exposure with soap and water and changed clothes.There was a very small amount of exposure to the patient and family member reported.The exposed areas were immediately cleaned with soap and water and they were asked to follow up if any new developments occurred.Of note, the staff has made some adjustments in their practice and have switched to a different brand of infusion bags and have not had further incidents.

Manufacturer Narrative

Result - a sample was not received for evaluation.A review of the device history record cannot be completed as the lot number was not provided for this incident.The process was reviewed for the reported catalog number 515306, noting the visual inspections, membrane welding test, and leakage tests performed.Conclusion - bd was unable to duplicate or confirm the customer's indicated failure mode.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD INFUSION ADAPTER C100 WITH BUILT-IN PHASEAL¿ CONNECTOR
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5323733
• MDR Text Key: 34269977
• Report Number: 3003152976-2015-00001
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 515306
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other