MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE

Catalog Number 309620

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 was reported that bd¿ catheter tip syringe had a hole in the wrapper.The following information was provided by the initial reporter: material no.: 309620 batch no.: 8270725.It was reported that there was a hole in the wrapper.Per email: hole in wrapper.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.

Event Description

It was reported that bd¿ catheter tip syringe had a hole in the wrapper.The following information was provided by the initial reporter: material no.: 309620 batch no.: 8270725 it was reported that there was a hole in the wrapper.Per email: hole in wrapper.

• Brand Name: BD¿ CATHETER TIP SYRINGE
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8578189
• MDR Text Key: 145758683
• Report Number: 1911916-2019-00438
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 309620
• Device Lot Number: 8270725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other