MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS MDS-21NRFIT; PISTON SYRINGE

Catalog Number MDS-21NRFIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd syringe nrfit¿ slip was involved in a study and patient "collapsed during the puncture attempt and then wanted a general anesthesia." the following information was provided by the initial reporter: the above mentioned customer is participating in the mds-21nrfit001 study.The patient performed a spinal anesthesia with the following nrfit devices on (b)(6) 2024.However, the anesthetic medication was not successfully injected through the bd syringe as patient collapsed during the puncture attempt and then wanted a general anesthesia.Bd syringe nrfit lot number: 83149, ancillary device used (catalogue number/type/size): 400066/bd blunt filter nrfit needle/18g x 1 1/2(1.2 mm x 40 mm).Bd blunt fill or blunt filter nrfit needle lot number: 3045501.Bd syringe nrfit (catalog number/type/size): 400051/syringe nrfit slip/5ml.Bd spinal nrfit needle set lot number : 2109032.An adverse event "hypotension with bradycardia" was reported on (b)(6) 2024 and resolved on the same day.The adverse event was treated with akrinor 100mg.And patient was laid down.Device was removed and subject was given general anesthesia.Relationship to spinal needle: not related.Relationship to syringe: not related.Relationship to introducer: not related.Relationship to ancillary devices: not related.Relationship to procedure: possible.The adverse event occurred after using the device.The event is possibly related to procedure.This complaint has been reported because it has a possible relationship with the procedure.

Event Description

Adverse event with no malfunction, device unrelated.Adverse event related to procedure only.

Manufacturer Narrative

(b)(4) follow up report #2 for corrections.This complaint was found to be a duplicate after the mdr was submitted, please refer to (b)(4).The manufacturing plant was incorrect in the initial mdr.The manufacturing plant should be becton dickinson - franklin lakes, nj / 07417.Event details have been updated: adverse event with no malfunction, device unrelated.Adverse event related to procedure only.Medical device brand name, medical device catalog #, and medical device lot # have been updated to reflect the nrfit anesthesia study.No product identified as cause for the adverse event.Event related to procedure only.Pma/510k has been updated to na.

Event Description

No additional information.

Manufacturer Narrative

(b)(4) follow up mdr for device evaluation since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: MDS-21NRFIT
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18705138
• MDR Text Key: 335407048
• Report Number: 1213809-2024-00081
• Device Sequence Number: 1
• Product Code: QEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS-21NRFIT
• Device Lot Number: MDS-21NRFIT
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/05/2024; 03/05/2024
• Supplement Dates FDA Received: 03/06/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other