MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405180

Device Problem Complete Blockage (1094)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that 1bd¿ quincke spinal needle each from lots 2073452 and 2159499 were clogged during use.The following information was provided by the initial reporter: "the tips are not potent and cannot inject/use them".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2073452.Medical device expiration date: 28-feb-2027.Device manufacture date: 22-apr-2022.Medical device lot #: 2159499.Medical device expiration date: 31-may-2027.Device manufacture date: 29-jul-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that 1bd¿ quincke spinal needle each from lots 2073452 and 2159499 were clogged during use.The following information was provided by the initial reporter: "the tips are not potent and cannot inject/use them.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 10-apr-2023.H6: investigation summary: eleven unopened samples from batch 2073452 and four from batch 2159499 received by our quality team for investigation.Upon visual evaluation, no defects or issues observed.Further testing was conducted, needles were not clogged.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

Event Description

It was reported that 1bd¿ quincke spinal needle each from lots 2073452 and 2159499 were clogged during use.The following information was provided by the initial reporter: "the tips are not potent and cannot inject/use them".

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16375785
• MDR Text Key: 309588366
• Report Number: 2618282-2023-00013
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: 00382904051808
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K210978
• 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: 05/08/2023

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: 405180
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/08/2023; 05/08/2023
• Supplement Dates FDA Received: 03/21/2023; 05/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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