MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 381423

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Investigation: investigation summary: dhr review was performed on the following lot number: 7193609 ¿ the lot number was built on afa line 2, from july 17, 2017 thru july 25, 2017. The review of the dhr revealed: according to the line clearance for zone 5; the previous work was item number was ns381523, lot number 2142680 7193609 ¿ the lot number was packaged on afa packaging 11, from july 21, 2017 thru july 26, 2017. The review of the dhr revealed: according to the line clearance positions a, b and c; the previous work was item number was ns381444, lot number 7191687. Observations and testing: received one unused iag 22ga unit in a sealed package from the lot number 7193609. Observed the product inside of the sealed package was an 18ga unit. The print on the paper top web shows that the ref # identifies the product as 381423; which is 22ga iag. The returned unit provided for evaluation revealed 18ga unit sealed in22ga package. Investigation conclusion: the defect of label content incorrect; as stated in the subject of the pir was confirmed with the returned unit. The print on the paper top web shows that the ref # identifies the product as 381423; which is 22ga iag. The product inside the sealed package is an 18ga unit. The customer experienced was confirmed with the evaluation performed on the returned unit. Root cause description: relationship of device to the reported incident: packaging process comment: the product associated with this incident was caused by an inadequate line clearance per the packaging line clearance.

Event Description

It was reported that an 18 g catheter was found in a 22 g x 1. 00 in. Bd insyte¿ autoguard¿ shielded iv catheter package before use. No injury or medical intervention.

• Brand Name: 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6989144
• MDR Text Key: 91362714
• Report Number: 1710034-2017-00285
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814238
• UDI-Public: 30382903814238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 381423
• Device Lot Number: 7193609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/30/2017 Patient Sequence Number: 1