MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 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 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

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 the syringe catheter tip 2oz experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 309620, batch no.: 9240836.Verbatim: customer called and stated they ordered 1 case of the 60 ml bd¿ catheter tip syringe but received a 50 ml syringe, the label on the outside states 60ml.Item 309620 lot 9240836.

Manufacturer Narrative

The report mfr# of 1911916-2019-01154 has been deemed not reportable after further review and will be canceled.There was no report of serious injury, medical intervention, or reportable device malfunction.General dissatisfaction of the product does not impact the intended use of the device which would not lead to harm or serious injury to the clinician or patient.As a result mfr# 1911916-2019-01154 is null and void.

Event Description

It was reported that the syringe catheter tip 2oz experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 309620; batch no.: 9240836.Verbatim: customer called and stated they ordered 1 case of the 60 ml bd¿ catheter tip syringe but received a 50 ml syringe, the label on the outside states 60ml.Item 309620; lot 9240836.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9273284
• MDR Text Key: 194817118
• Report Number: 1911916-2019-01154
• 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: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309620
• Device Lot Number: 9240836
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other