MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405129

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 300 bd whitacre¿ spinal needles had a mix of product types in the pack.The following information was provided by the initial reporter: "distributor received the stocks (whitacre) kept in warehouse, when he open the box for supply he found that spinal needle mix inside whitacre box.".

Event Description

It was reported that 300 bd whitacre¿ spinal needles had a mix of product types in the pack.The following information was provided by the initial reporter: "distributor received the stocks (whitacre) kept in warehouse, when he open the box for supply he found that spinal needle mix inside whitacre box.".

Manufacturer Narrative

H.6.Investigation: photos received for investigation.Upon visual inspection, the boxes appear badly damaged, which gives us indications that they have been handled after our shipment.We are missing information on the second lot number and cannot determine that the mix was produced at our plant.A device history review was performed for reported lot 2109002, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.There was about two months difference between the two manufactures, therefore the mixture was not produced in our plant as it is very unlikely because the two batches did not coexist in the plant.Therefore, it can be concluded that there could not have been any mixing of products during sterilization as there is a 2 months difference between the three batches.Based on the photo, we can verify sku 405129 (lot 2109002) under invoice no.1196618389 - has been shipped in full carton and as we did not open the carton in distribution center, therefore we cannot confirm the product mix and sku 405129 (lot 2109002) under invoice no.1196618412 - has been shipped in 4 shipping cartons with intact condition and the shipping carton repacked into a master carton.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 investigation, possible root cause is associated with a repackaging at the distribution center when shipping the quantity requested on the invoice by the customer and human counting or needle mix-up failure in the preparation of the shipment.H3 other text : see h.10.

• Brand Name: BD WHITACRE¿ SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13261364
• MDR Text Key: 285483132
• Report Number: 3003152976-2021-00910
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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: Other
• Device Catalogue Number: 405129
• Device Lot Number: 2109002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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