MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD FILTER NEEDLE 19G X 1/2 IN; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number 305200

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1139381, medical device expiration date: na, device manufacture date: 2005-02-03, medical device lot #: 4351512, medical device expiration date: na, device manufacture date: 2005-02-03, (b)(4).Investigation summary: a device history record review was not possible due to the date of production of provided lot numbers 1139381 and 4351512.One lot was produced in 2011 and other in 2014.In 2011 and 2014 the expiration date was not a requirement for printing on the labels.Based on the information given, the customer has expired product.There are quality controls currently in place to detect the defect of label content missing during the production process.Further action has not been determined necessary at this time.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.Investigation conclusion: these lot #s were produced during 2011 and 2014; at that time, the expiration date was not a requirement for printing it on the labels.A review of the applicable fmea/eura ((b)(4)) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause description: the customer has expired product.Rationale: based on the investigation carried out and with the information provided the symptom reported by the customer is confirmed.It is recommended that rcc/hypodermic marketing informs the customer they have expired products- both lot #s.

Event Description

It was reported that an unspecified number of bd filter needles 19g x 1/2 in experienced missing label information which was noted prior to use.The following information was provided by the initial reporter: material no: 305200, batch no: 1139381, 4351512.Caller has various lot numbers of 305200.Some have expiration dates listed, some do not.Lot numbers 1139381 and 4351512 do not have expiration dates listed.

• Brand Name: BD FILTER NEEDLE 19G X 1/2 IN
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10723549
• MDR Text Key: 214153057
• Report Number: 1911916-2020-00968
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: 30382903052005
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305200
• Device Catalogue Number: 305200
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• 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
• Patient Outcome(s): Other