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

Model Number 309620

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was performed for provided lot number 62254.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, five physical samples were received and each of them was in a sealed packaging blister.A visual inspection was performed to the packaging blister top web, all the graphics are acceptable no defects were observed.The syringe scale printing was also inspected.Three of the five syringes have no defects or imperfection on the scale, two of them have imperfection in the scale printing and one has the 25 and 26 mark lines with a missing piece of the line (1/16").No other imperfection was observed.The other syringe has a similar imperfection of 1/16" at the 23 mark line.These readings are all within specification.Investigation conclusion: our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Root cause description: a cause for this defect could not be provided as the readings are within specification and no smudging of the lines or wording was observed.Rationale: further action has not been determined necessary at this time.

Event Description

It was reported that syringe catheter tip 60ml had scale marking issues on 40 occasions.The following information was provided by the initial reporter: smudging of the lines and wordings.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10939234
• MDR Text Key: 221011958
• Report Number: 1911916-2020-01092
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• 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: 0062254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2020
• 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