MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382523

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 hair was found inside the bd insyte¿ autoguard¿ bc shielded iv catheter before use.The following information was provided by the initial reporter: "per customer, hair inside of the sterile product.".

Event Description

It was reported that a hair was found inside the bd insyte¿ autoguard¿ bc shielded iv catheter before use.The following information was provided by the initial reporter: "per customer, hair inside of the sterile product.".

Manufacturer Narrative

Correction: the date of event has been updated.The following information has been corrected: b.2.Date of event: (b)(6) 2019.

Manufacturer Narrative

H.6.Investigation summary: a bd quality engineer inspected the sample provided.Bd received 3 insyte autoguard 22ga units within sealed packages from lot number 9007821.All components within were intact.Visual examination revealed a strand of hair on the seal and around the needle covers within sealed packages.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to human error in the packaging process.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that a hair was found inside the bd insyte¿ autoguard¿ bc shielded iv catheter before use.The following information was provided by the initial reporter: "per customer, hair inside of the sterile product.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8832135
• MDR Text Key: 153855560
• Report Number: 1710034-2019-00794
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 382523
• Device Lot Number: 9007821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other