MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD YALE¿ QUINCKE POINT SPINAL NEEDLE WITHOUT INTRODUCER

Catalog Number 405253

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Investigation results: summary: no photos or samples were received in the (b)(4)plant for evaluation therefore the failure mode could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Three retained samples were visually inspected with no defects found, the steel was properly flared, the traction power between the cannula and the hub was acceptable, the traction power between the stylet and the cube were also acceptable and after performing the traction power test, it was verified the steel was properly blasted.Based upon the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Conclusion: customer complaint about the separation of the needle and the plastic part (hub).No pictures or samples are available.Three (3) retained samples were checked: no defects were found.Visual inspection shows no defects.The steel is properly flared in the 3 samples.Traction power between the cannula and the hub is acceptable in the 3 samples.Traction power between the stylet and the cube is also acceptable.After having performed the traction power test, it was verified that the steel is properly blasted.No non-conformances were found during manufacturing process (assembly lot#7159470).Needle defect- other.Customer complaint about the separation of the needle and the plastic part (hub).No pictures or samples are inspection and test - spinal needles are manufacturing in (b)(4) plant.During manufacturing process, several tests and inspections are carried out to avoid faulty parts.According to ae-301 (current version), it is verified that the cannulas are properly flared.Traction power between the cannula and the hub (= 12 lb), and between the stylet and the cube (= 5 lb) is measured during manufacturing process according to ae-500 and after sterilization according to ae-600 (frequency is also established in this procedures).Conclusion - no samples or pictures are available.No defects were found in retained samples.No qn's were found during dhr review.Root cause: no samples or pictures are available.No defects were found in retained samples.No qn's were found during dhr review.Rationale: based on the severity and frequency of the defect (according to ps-001) a cid was open (b)(4).No capa is required.

Event Description

It was reported while using a bd yale¿ quincke point spinal needle without introducer, there was separation between the ¿metal pat of the needle and the plastic base.¿ the procedure was interrupted and sterile pliers were used to remove the remaining needle piece which was stuck in the patient¿s spine.There was no additional report of additional treatment.

• Brand Name: BD YALE¿ QUINCKE POINT SPINAL NEEDLE WITHOUT INTRODUCER
• Type of Device: SPINAL 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7426454
• MDR Text Key: 105327648
• Report Number: 3003152976-2018-00127
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 405253
• Device Lot Number: 1706014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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): Required Intervention