MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ LUER TIP CAP TRAY; LIQUID MEDICATION DISPENSER

Catalog Number 308341

Device Problem Leak/Splash (1354)

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

Event Date 02/02/2023

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 unspecific number of bd¿ luer tip cap tray experienced leakage.The following information was provided by the initial reporter: the bd¿ luer tip cap tray of 10, black color, sterile all leak.Five different staff members tried to make these work and all of them leak.Xxxxx has set them aside and they are ready to be shipped back to bd once shipping labels are received.No patient harm because of the leakage just frustration from not having the product work as it should.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that unspecific number of bd¿ luer tip cap tray experienced leakage.The following information was provided by the initial reporter: the bd¿ luer tip cap tray of 10, black color, sterile all leak.Five different staff members tried to make these work and all of them leak.Xxxxx has set them aside and they are ready to be shipped back to bd once shipping labels are received.No patient harm because of the leakage just frustration from not having the product work as it should.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 16-mar-2023.H6: investigation summary: samples received by our quality team for investigation.One tray with two luer tip cap unused and sealed were provided by the customer as evidence for this investigation.Also, five different syringes with a tip cap placed at the tip of the syringe were received.Upon visual evaluation, no defects or damaged observed on the tip caps.The packaging process was evaluated and there is no process step or malfunction that would cause the reported issue.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the investigation results, no manufacturing related defects could be identified therefore, a cause for the reported incident could not be determined.

Event Description

It was reported that unspecific number of bd¿ luer tip cap tray experienced leakage.The following information was provided by the initial reporter: the bd¿ luer tip cap tray of 10, black color, sterile all leak.Five different staff members tried to make these work and all of them leak.Xxxxx has set them aside and they are ready to be shipped back to bd once shipping labels are received.No patient harm because of the leakage just frustration from not having the product work as it should.

• Brand Name: BD¿ LUER TIP CAP TRAY
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16464864
• MDR Text Key: 310500453
• Report Number: 2618282-2023-00015
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 308341
• Device Lot Number: 2307934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1