MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20028E

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical devices: 11448964; hospira 1000ml bag 0.9% nacl injection, (b)(4), lot 64-026jt, exp 1 apr 2018; baxter 250ml exactamix ref (b)(4), lot 1102113, exp 2018/11.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported that the iv set broke off during an unspecified infusion.Although requested there is no additional event details provided by the customer.

Manufacturer Narrative

Concomitant medical devices: non-bd spike adaptor; short non-bd extension tubing; spiro connector; therapy date unknown.No available code for undetermined or unknown cause.The customer¿s report that the iv set broke off was confirmed.During visual inspection it was observed that the male luer spin collar was easily removed from the set.Visual inspection under magnification showed cracks around the male luer spin collar.Tool marks were not observed.The male luer spin collar was reattached to the male luer body.Upon connecting to a female luer, the male luer spin collar easily slipped upon tightening.It is possible that the existing cracks may have caused a widening of the functioning diameter of the spin collar enabling the slippage.Functional and pressure testing was performed; no leaking was observed.The root cause of the component breakage was not identified.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5761853
• MDR Text Key: 48553903
• Report Number: 9616066-2016-00872
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1