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

Catalog Number 381212

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A 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 (b)(4).Has been listed in manufacturer and mfr site and (b)(4) registration number has been used for the manufacture report number.Device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a needle break occurred during use with a bd insyte¿ iv catheter.The following information was provided by the initial reporter, "had needle break off inside a child yesterday.Had to get plastics to remove needle.This is the only incident she is aware of.Does not have faulty product of batch.".

Manufacturer Narrative

Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported that a needle break occurred during use with a bd insyte¿ iv catheter.The following information was provided by the initial reporter, "had needle break off inside a child yesterday.Had to get plastics to remove needle.This is the only incident she is aware of.Does not have faulty product of batch.".

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9099167
• MDR Text Key: 163956381
• Report Number: 2243072-2019-02080
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: 30382903812128
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381212
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention