MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Catalog Number 309620

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the syringe catheter tip 2oz has been found experiencing 11 occurrences of incorrect label information before use.The following has been provided by the initial reporter: it was reported that customer placed order for 60ml syringes but received 50ml syringe.We have an issue with 60ml syringe catheter.This week we placed two different orders and we received 50ml syringes.The bd packaging is labeled incorrectly and we noticed they are all coming from the same lot number.

Manufacturer Narrative

New dt has been created, this complaint is no longer reportable.

Event Description

It has been reported that the syringe catheter tip 2oz has been found experiencing 11 occurrences of incorrect label information before use.The following has been provided by the initial reporter: it was reported that customer placed order for 60ml syringes but received 50ml syringe.Product description summary: we have an issue with 60ml syringe catheter.This week we placed two different orders and we received 50ml syringes.The bd packaging is labeled incorrectly and we noticed they are all coming from the same lot number.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9208988
• MDR Text Key: 194632457
• Report Number: 1911916-2019-01102
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309620
• Device Lot Number: 9218113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other