MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Model Number 309620

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: one photo was provided for evaluation.It shows a packaging box label with 50ml and a packaging blister of a 60ml.Both products are labeled as catalog# 309620.Based on a business decision, the 60ml syringe was phased out, and the 50ml introduced replacing the 60ml.The hypodermic platform team confirmed to keep the same catalog# for both products.Based on the investigation and with the photo provided, the symptom reported by the customer is confirmed.Both products comply with the specifications at the time of each production.The 60ml is no longer produced, only 50ml.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Trend analysis has shown that this is the only complaint received for this condition and lot number.As such, it appears that the sample shown in the photo provided is likely due to an isolated occurrence.No further action seems to be warranted at this time.Complaints received for this device and reported condition would continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for the identification of emerging trends.Investigation conclusion: this is the 1st complaint for lot # 0052176 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Based on the investigation and with the photo provided, the symptom reported by the customer is confirmed.Both products comply with the specifications at the time of each production.The 60ml is no longer produced, only 50ml.Rationale: capa not required at this time.

Event Description

It was reported that an unspecified number of syringe catheter tip 2oz experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no.309620 batch no.0052176.Verbatim: reported issue: the item #s for the 2 different items are the same for the 50ml and 60ml syringe.Customer is needing 60ml.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• 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 ; 8015652341
• MDR Report Key: 10269476
• MDR Text Key: 199131597
• Report Number: 1911916-2020-00641
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: 0052176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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
• Patient Outcome(s): Other