MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE WITH FILTER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305211

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary four (4) photos were provided by the customer for investigation.The first (1st) photo shows the ifu in (b)(6).The second (2nd) photo shows a label in (b)(6).The third (3rd) photo shows the coc in english.Under the sterility section it stated that the ¿product is primarily sterilized via gamma radiation.¿ the fourth (4th) photo shows the top web of a blister pack.On each of the blister packs it is stated that the product is ¿sterilized using irradiation¿.Per procedure this batch was sterilized using gamma radiation.Complaints received for this device and reported condition will 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 identification of emerging trends.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.Investigation conclusion a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of label content incorrect for lot #7264720 item #305211.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Root cause description per procedure this batch was sterilized using gamma radiation.Rationale per procedure this batch was sterilized using gamma radiation.As a consequence, no corrective or preventative actions are proposed in the scope of this complaint.Any additional questions or concerns should be directed at the bd regulatory group.

Event Description

It was reported that before use of the bd¿ blunt fill needle with filter the label on the box stating the method of sterilization is not consistent in the english and (b)(6) translation.Foreign complaint the following information was provided by the initial reporter: the sterilization method is eo in the (b)(6) ifu, (b)(6) labels; while gamma irradiation in the coc english revision and the single unit package.The information is not consistent in the english and (b)(6).

Event Description

It was reported that before use of the bd¿ blunt fill needle with filter the label on the box stating the method of sterilization is not consistent in the english and chinese translation.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the sterilization method is eo in the chinese ifu, chinese labels; while gamma irradiation in the coc english revision and the single unit package.The information is not consistent in the english and chinese.

Manufacturer Narrative

H.5.Labeled for single use: yes.

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH FILTER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8755949
• MDR Text Key: 150157394
• Report Number: 1911916-2019-00658
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903052111
• UDI-Public: 30382903052111
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 305211
• Device Lot Number: 7264720
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other