MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE FILTER 19X1-1/2 TW NS; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305202

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na investigation summary: it was reported during an in incoming inspection the outside supplier label did not match the inside label.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a bulk plastic bag label with sku 305202, lot 0321887, quantity 2000, date 02-04-21, line #7, bag 239.The other photo shows a case label sku 305202, lot 0363896.Both lot numbers are sku 305202, were produced on the same day and by the same production line.Based on the labels issued and used it is possible case labels of lot 0363896 were used in lot 0321887.A device history record review was completed for provided material number 305202, lot 0363896.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 photo sample analysis the symptom reported by the customer is confirmed.In order to mitigate this defect, refreshing training will be done with the associates.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 4,000 needle filter 19x1-1/2 tw ns experienced incorrect label information.The following information was provided by the initial reporter: material no: 305202 batch no: 0363896 the entire (b)(4) needles were rejected because of the labeling, this is part of our incoming inspection check.Bd lot 0363896 was rejected at incoming inspection due to incorrect labeling.The outside label has a discrepancy with the inside label.There appears to be a discrepancy with the part number, lot, and qty.The disposition is to return this lot.

• Brand Name: NEEDLE FILTER 19X1-1/2 TW NS
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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: 11841021
• MDR Text Key: 252103272
• Report Number: 1911916-2021-00457
• Device Sequence Number: 1
• Product Code: GAA
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305202
• Device Lot Number: 0363896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• 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