MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381423

Device Problems Fail-Safe Design Failure (1222); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/02/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.The initial reporter also notified the fda on 06/19/2017 via medwatch # mw 2601800000-2017-8004.Device manufacture date: unknown.Results: a sample or photo is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that a nurse received a needle stick injury to her forearm when the safety on a unknown intima iv catheter system did not cover the needle.

Event Description

It was reported that a nurse received a needle stick injury to her forearm when the safety on a bd insyte¿ autoguard¿ shielded iv catheter did not cover the needle.

Manufacturer Narrative

Additional information: catalog # 381423.Corrected the following fields: describe event or problem: it was reported that a nurse received a needle stick injury to her forearm when the safety on a bd insyte¿ autoguard¿ shielded iv catheter did not cover the needle.Medical device brand name: bd insyte¿ autoguard¿ shielded iv catheter.Medical device catalog #: 381423.(b)(4).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• 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
• MDR Report Key: 7028793
• MDR Text Key: 91939931
• Report Number: 9610847-2017-00145
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 381423
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other