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

Catalog Number 405128

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 25 quincke needles were found in the box of bd whitacre¿ pencil spinal needles with introducer.The following information was provided by the initial reporter: "hospital has complained today that they have found 25 nos.Of spinal needle quincke type point- 27g ( code: 405127) in batch no.2007004, expiry: 06/2025, mrp: 195.50.".

Manufacturer Narrative

H.6.Investigation: photo received for investigation, upon visual inspection, the photo of the box shows that it is identified on the label with lot number 1912012 and with reference(b)(4) which corresponds to whitacre set with 27ga x 3.50in gauge introducer.Inside the box are spinal needles with lot number 2007004 with reference (b)(4) corresponding to 27ga x 3.50in gauge spinal needle.The dhrs of the two lots that are mixed in the same box have been checked, and they were packed in different months.A device history review was performed for reported lots 1912012, 2007004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Lot 1912912 was packed since december 19, 2019 and in which no nonconformity or deviation was recorded that could be related to this event.Lot 2007004 was started packaging on july 06, 2020 and in which no nonconformity or deviation was recorded that could be related to this event.Therefore, there was about 6 months difference between the two manufactures it is impossible that the mixing occurred in our plant as it is very unlikely because the two batches did not coexist in the plant.The batches were sterilized, lot 1912012 (ref.(b)(4)) - date of sterilization: 14-jan-2020 and , lot 2007004 (ref.405127) - date of sterilization: 13-jul- 2020.Therefore, it can be concluded that there could not have been product mixing during sterilization, as there is 6 months difference between one and the other.Additionally, the distribution center have not evidenced any nonconformity or deviation in the whole shipping process.Therefore, there was about 6 months difference between 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.H3 other text : see h.10.

Event Description

It was reported that 25 quincke needles were found in the box of bd whitacre¿ pencil spinal needles with introducer.The following information was provided by the initial reporter: "hospital has complained today that they have found 25 nos.Of spinal needle quincke type point- 27g ( code: 405127) in batch no.2007004, expiry: 06/2025, mrp: 195.50.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/27/2022.The following field was updated due to corrected information: h.6.Imdrf annex c grid: c160504 - packaging contains incorrect device.H.6.Investigation: photo and sample received for investigation.Upon visual inspection, the photo of the box shows that it is identified on the label with lot number 1912012 and with reference 405128 which corresponds to whitacre set with 27ga x 3.50in gauge introducer.Inside the box are spinal needles with lot number 2007004 with reference 405127 corresponding to 27ga x 3.50in gauge spinal needle.Upon visual observation of the physical sample, the box is broken and damaged.The dhrs of the two lots that are mixed in the same box have been checked, and they were packed in different months.A device history review was performed for reported lots 1912012, 2007004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Lot 1912912 was packed since december 19, 2019 and in which no nonconformity or deviation was recorded that could be related to this event.Lot 2007004 was started packaging on july 06, 2020 and in which no nonconformity or deviation was recorded that could be related to this event.Therefore, there was about 6 months difference between the two manufactures it is impossible that the mixing occurred in our plant as it is very unlikely because the two batches did not coexist in the plant.The batches were sterilized, lot 1912012 (ref.405128) - date of sterilization: 14-jan-2020 and , lot 2007004 (ref.405127) - date of sterilization: 13-jul- 2020.Therefore, it can be concluded that there could not have been product mixing during sterilization, as there is 6 months difference between one and the other.Additionally, the distribution center have not evidenced any nonconformity or deviation in the whole shipping process.Therefore, there was about 6 months difference between 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

It was reported that 25 quincke needles were found in the box of bd whitacre¿ pencil spinal needles with introducer.The following information was provided by the initial reporter: "hospital has complained today that they have found 25 nos.Of spinal needle quincke type point- 27g ( code: 405127) in batch no.2007004, expiry: 06/2025, mrp: 195.50.".

• Brand Name: BD WHITACRE¿ PENCIL SPINAL NEEDLE WITH INTRODUCER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12870576
• MDR Text Key: 283173877
• Report Number: 3003152976-2021-00788
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

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: 405128
• Device Lot Number: 1912012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/07/2022; 01/27/2022
• Supplement Dates FDA Received: 01/18/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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