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

Model Number 309620

Device Problem Packaging Problem (3007)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported that the sterile items were stuck in flaps of case and could not be removed without compromising the sterile packaging.To aid in the investigation, one case box and one photo was provided for evaluation by our quality team.The case box has four samples.Two of them are loose inside and two are glued to the case box flap.The photo provided shows the samples glued to the case box flap.This defect can occur if the robot at the packaging machine misplaced the set of four packaging blisters, then when the case box was glued and closed the parts ended up glued to the case box flap.A device history record review was completed for provided material number 309620, lot number 0303777.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample and photo sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd¿ catheter tip syringe was packaging was "stuck" in the flaps of the case box and was damaged when removing it.The following information was provided by the initial reporter: "sterile items stuck in flaps of case, could not be removed without compromising sterile packaging.".

• 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11754803
• MDR Text Key: 264184567
• Report Number: 1911916-2021-00390
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• 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
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: 0303777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• 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