MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 2OZ CATH TIP BNS; IRRIGATING SYRINGE

Catalog Number 301037

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is 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 the syringe 2oz cath tip bns experienced a mix of product types in a pack.The following information was provided by the initial reporter: material no: 301037 batch no: 0014920 we received some materials that do not match the description, and need returned.

Event Description

It was reported that the syringe 2oz cath tip bns experienced a mix of product types in a pack.The following information was provided by the initial reporter: material no: 301037 batch no: 0014920.We received some materials that do not match the description, and need returned.

Manufacturer Narrative

Additional information has been received clarifying that this is an incident of an incorrect device being received.This incident is unlikely to result in harm or serious injury, and is not reportable.The initial mdr submission, (mfr report # 1911916-2021-00191), can therefore be disregarded.

• Brand Name: SYRINGE 2OZ CATH TIP BNS
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11445186
• MDR Text Key: 264282514
• Report Number: 1911916-2021-00191
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301037
• Device Lot Number: 0014920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1