MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CADD® EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7105-24

Device Problem Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/02/2012

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: the cadd® extension set is packaged in an arrow select kit - model #: ask-05503-upm1, lot # 23f16d0764.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cadd® extension set connector was difficult to unscrew overnight, which delayed operative procedures in an urgent situation.The patient had a 2l hemorrhage in the labor-delivery-recovery that required urgent transport and resulted in a 7l estimated blood loss.No permanent injury was reported.

Manufacturer Narrative

One used cadd® extension set was returned for investigation, along with an unknown component.Visual inspection was performed and no defects were found in the returned sample.A manufacturing review of a similar device was performed and no discrepancies were found.As no defect was found in the product nor manufacturing process, the complaint was not confirmed.

• Brand Name: CADD® EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5991904
• MDR Text Key: 56094673
• Report Number: 2183502-2016-02153
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7105-24
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/20/2018
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ARROW SELECT EPIDURAL CATHETERIZATION KIT
• Patient Outcome(s): Life Threatening