MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 60ML; IRRIGATING SYRINGE

Catalog Number 309620

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 06/06/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0170212.Medical device expiration date: 2025-05-31.Device manufacture date: 2020-06-18.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: it was reported the syringe had a broken piece, the liquid leaked out, and the customer was not able to pull liquid out of the syringe.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a 50ml syringe catheter tip and the other photo shows the top part of a syringe with barrel flange damaged.A device history record review was completed for provided material number 309620, lot number 0170212.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Investigation conclusion: 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.Root cause description: based on the investigation and with no sample analysis the symptom of aspirate/ draw (cannot/ difficult) reported by the customer could not be confirmed and with no physical sample analysis a probable root cause could not be offered.Rationale: capa not required at this time.

Event Description

It was reported that syringe catheter tip 60ml was damaged and leaked.The following information was provided by the initial reporter: it was reported that customer is not able to pull liquid out of the syringe, and leaked out due to possible pin holes.Also syringe had a broken piece.

• Brand Name: SYRINGE CATHETER TIP 60ML
• 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: 12125364
• MDR Text Key: 261059614
• Report Number: 1911916-2021-00635
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: 00382903096206
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309620
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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