MAUDE Adverse Event Report: BD CARIBE LTD. KIT PERISAFE 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION KIT

Catalog Number 400273

Device Problem Packaging Problem (3007)

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

Event Date 10/10/2019

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 kit perisafe 18ga 3-1/2 in weiss has been found with poor perforation before use.The following has been provided by the initial reporter: when you open the set in some cases it gets stuck in the blister where it comes from, having to perform strong movements to make it descend to the sterile part and the protective cap disconnects.

Event Description

It has been reported that the kit perisafe 18ga 3-1/2in weiss has been found with poor perforation before use.The following has been provided by the initial reporter: when you open the set in some cases it gets stuck in the blister where it comes from, having to perform strong movements to make it descend to the sterile part and the protective cap disconnects.

Manufacturer Narrative

Investigation: bd has been provided with a sample for catalog 400273 lot 8115821 to investigate for this record.The returned sample was examined and the top lid was removed from the blister tray with no constrictions or excess force was needed to open the sample.Seal was smooth without channels nor incomplete seal.Unfortunately, as a result, bd was unable to verify the reported issue.In addition, a definitive root cause was unable to be determined and no issues regarding packaging, manufacturing or material/process/methods/procedures has been affected in the last years.Top web retained at the device history review for complaint lot was measured and comply with thickness specification.

• Brand Name: KIT PERISAFE 18GA 3-1/2IN WEISS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9246601
• MDR Text Key: 202020610
• Report Number: 2618282-2019-00272
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• PMA/PMN Number: K953790
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 400273
• Device Lot Number: 8115821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other