MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE¿ IV CATHETER

Catalog Number	381234
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use of the bd insyte¿ iv catheter that the iv catheter did not retract fully causing needle stick.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
The nonconformance cannot be confirmed as no sample was returned for investigation.No dhr was reviewed as the batch number is unknown.The complaint will be reopened if the sample is returned for investigation.
Event or Problem Description
It was reported that during use of the bd insyte iv catheter that the iv catheter did not retract fully causing needle stick.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Device single use?: no.Device returned to manufacturer: no.This supplemental mdr also corrects the event description: it was reported that during use of the bd insyte¿ iv catheter that the iv catheter did not retract fully which caused a needle stick.Medical intervention is unknown.
Event or Problem Description
It was reported that during use of the bd insyte¿ iv catheter that the iv catheter did not retract fully which caused a needle stick.Medical intervention is unknown.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7706983
• Report Number: 2243072-2018-00994
• Device Sequence Number: 19468254
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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
• Operator of Device: Other
• Device Catalogue Number: 381234
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 06/28/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/03/2018; 09/12/2018
• 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