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

Catalog Number 309620

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported the whole catheter tip of the syringe is discolored.To aid in the investigation, one sample in a sealed packaging blister was received for evaluation by our quality team.A visual inspection was performed.The cap was removed and is clear.The syringe barrel catheter tip has discoloration.We tried to remove it with alcohol and it was not possible.It is embedded degraded resin.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 309620, lot number 0062238.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Frequency of inspections was increased to mitigate the risk of these escapes.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.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: probable root cause.Molding process.The embedded degraded resin occurs at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the system of the tooling mold and press.The degraded resin can break loose and be molded into components.The inspection frequency was increased to mitigate the risk of these escapes.Rationale: capa not required at this time.

Event Description

It was reported that syringe catheter tip 60ml catheter tip was discolored.The following information was provided by the initial reporter: whole catheter tip of syringe discolored.

• 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: 12006112
• MDR Text Key: 261141764
• Report Number: 1911916-2021-00558
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: 00382903096206
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309620
• Device Lot Number: 0062238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• 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