MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD; INTERVASCULAR CATHETER

Catalog Number	381923
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one 22g x 1.00in (0.9 x 25 mm) insyte autoguard has experienced needle retraction failure and a needle stick injury after use.The following has been provided by the initial reporter: activation button did not work.After inserting iv catheter using insyte autoguard, activation button did not retract the needle causing the nurse on duty get prick him.Activation of safety feature of insyte autoguard did not work after inserting the catheter.
Additional Manufacturer Narrative
H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record was performed and no quality issues were found during production.
Event or Problem Description
It has been reported that one 22g x 1.00in (0.9 x 25 mm) insyte autoguard has experienced needle retraction failure and a needle stick injury after use.The following has been provided by the initial reporter: activation button did not work.After inserting iv catheter using insyte autoguard, activation button did not retract the needle causing the nurse on duty get prick him.Activation of safety feature of insyte autoguard did not work after inserting the catheter.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8777546
• Report Number: 1710034-2019-00743
• Device Sequence Number: 2665919
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: 382903819232
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 381923
• Device Lot Number: 8037850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other