MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.; INTRAVASCULAR CATHETER

Catalog Number 383313

Device Problem Material Puncture/Hole (1504)

Patient Problems Injury (2348); Needle Stick/Puncture (2462)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: results - a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - without a sample, an absolute root cause for this incident cannot be determined.If a sample is received, an investigation will be performed and a supplemental report submitted.

Event Description

It was reported that the clinician inserted the suspect device subcutaneously into the patient's abdomen.When the needle was being retracted, it pierced the plastic extension piece and the clinician sustained a needle stick injury.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6017381
• MDR Text Key: 57053460
• Report Number: 9610847-2016-00031
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383313
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 10/11/2016
• 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