MAUDE Adverse Event Report: BECTON DICKINSON SPINAL NEEDLE 25GA 3.50 IN FOR INDIA; MIA - NEEDLE, SPINAL, SHORT TERM

Catalog Number 405122

Device Problem Wrong Label (4073)

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

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a210106 - wrong label.

Event Description

While opening the pack of spinal quinke 25 its been found out that the spinal actually packed is 26.Based on photo provided, box labeled material 405122, lot 2303013.Product inside is material 405124, lot 2304020.

Manufacturer Narrative

Multiple photos were provided to our quality team for investigation.By visual inspection, the photos show boxes labeled as lot 2303013 item 405122, product inside lot 2304020 item 405124.They were packed in different months, lot 2303013 was packed from march 24, 2023 to march 28, 2023.Batch 2304020 began packaging on april 29, 2023 and was completed on may 03, 2023.A device history review was performed for reported lots 2303013,2304020 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Sterilization was performed on different dates, additionally they were also one month and a half apart.Batch 2303013 was sterilized on may 30, 2023, and batch 2304020 was sterilized on may 15, 2023.In addition, the records have been reviewed "review of damaged material in sterilized handling/storage procedures " and none related to those affected batches was found.Further investigation was performed at the distribution center and they did not evidence any nonconformity or deviation in the whole shipment process.Therefore, there was about 45 days difference between the two manufacturing and sterilization and there was no indication that the mixture could have been produced in our plant as it is very unlikely because the two batches did not coexist in the plant.Based on the photo, we can verify the reported failures.The product undergoes visual inspections prior to release, including verification that the product and quantity are appropriate within each package.All inspections of these batches were performed in accordance with procedure, and no notations related to the reported incident were noted.Based on the quality team's investigation, we are unable to identify a root cause related to our manufacturing process at this time.

Event Description

No additional information.

• Brand Name: SPINAL NEEDLE 25GA 3.50 IN FOR INDIA
• Type of Device: MIA - NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18186754
• MDR Text Key: 328989442
• Report Number: 3003152976-2023-00510
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405122
• Device Lot Number: 2303013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1