MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD WHITACRE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number UNKNOWN

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

Patient Problems Abscess (1690); Pain (1994)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the patient suffered from an infection in the lumbar spine after given an anesthesia injection with the unspecified bd¿ whitacre spinal needle.As a result, the patient was readmitted to the hospital on 2020-01-28 with "high fever, significantly elevated white blood cell count of 22,000, and back pain." blood cultures were drawn and revealed (b)(6) bacteremia in the bloodstream, which the patient was treated for along with "l4-l5 discitis, and an epidural abscess.".The following information was provided by the initial reporter: "alleges that prior to the total left knee replacement on (b)(6) 2019, plaintiff was given a spinal anesthesia block via single shot injection at the l3-l4 spine using a 25-gauge, 3.5-inch whitacre needle which was allegedly manufactured by bd.Plaintiff alleges that he was treated for ¿ (b)(6) bacteremia, l4-l5 discitis, and an epidural abscess.¿" on (b)(6) 2019, plaintiff, (pt name redacted) was a patient of defendant (hospital name redacted) and treated for primary osteoarthritis of the left knee and underwent a left total knee replacement.Prior to the total left knee replacement on (b)(6) 2019, plaintiff was given a spinal anesthesia block via single shot injection at the l3-l4 spine using a 25-gauge, 3.5-inch whitacre needle.The 3.5-inch whitacre needle was manufactured by defendant becton dickinson and company.On (b)(6) 2019, plaintiff, (pt name redacted) was noted to be (b)(6) for (b)(6) ).On (b)(6) 2019, (pt name redacted) was noted to be (b)(6) for (b)(6) ).Early post-operatively, plaintiff (pt name redacted) developed discitis and was readmitted with bacteremia on (b)(6) 2020.On (b)(6) 2020, (pt name redacted) presented to (hospital name redacted) with high fever, significantly elevated white blood cell count of 22,000, and back pain.Blood cultures taken on (b)(6) 2019, revealed the presence of high grade, persistent bacteremia with (b)(6) in (pt name redacted) bloodstream.Medical providers at (hospital name redacted) noted a diagnosis of (b)(6) bacteremia with possible spinal epidural abscess or discitis, status post epidural for knee replacement.Plaintiff (pt name redacted) was treated for (b)(6) bacteremia, l4-l5 discitis, and an epidural abscess.Plaintiff¿s history of infection states that his (b)(6) infection date is (b)(6) 2019.(pt name redacted) suffered damages including but not limited to, pain, suffering and disability causing the plaintiff to seek further medical treatment and incur further medical bills and the plaintiff, (pt name redacted), will in the future be caused great pain and suffering, required to seek medical treatment and incur medical bills.Plaintiff (pt name redacted) was treated for l4-l5 discitis and an epidural abscess during his (b)(6) 2019 admission to (hospital name redacted).After the (b)(6) 2019 procedure, (pt name redacted) had (b)(6) bacteremia in his lumbar spine.Pt name redacted) developed (b)(6) bacteremia from the procedure of the spinal anesthesia block via single shot injection at the l3-l4 spine performed on (b)(6) 2019.

Manufacturer Narrative

Correction: d.3.Medical device manufacturer: franklin lakes, nj.G.2.Manufacturing location: franklin lakes, nj.

Event Description

It was reported that the patient suffered from an infection in the lumbar spine after given an anesthesia injection with the unspecified bd¿ whitacre spinal needle.As a result, the patient was readmitted to the hospital on (b)(6) 2020 with "high fever, significantly elevated white blood cell count of 22,000, and back pain." blood cultures were drawn and revealed mrsa bacteremia in the bloodstream, which the patient was treated for along with "l4-l5 discitis, and an epidural abscess.".The following information was provided by the initial reporter: "alleges that prior to the total left knee replacement on (b)(6) 2019, plaintiff was given a spinal anesthesia block via single shot injection at the l3-l4 spine using a 25-gauge, 3.5-inch whitacre needle which was allegedly manufactured by bd.Plaintiff alleges that he was treated for ¿mrsa bacteremia, l4-l5 discitis, and an epidural abscess.¿" on (b)(6) 2019, plaintiff, (pt name redacted) was a patient of defendant (hospital name redacted) and treated for primary osteoarthritis of the left knee and underwent a left total knee replacement.Prior to the total left knee replacement on (b)(6) 2019, plaintiff was given a spinal anesthesia block via single shot injection at the l3-l4 spine using a 25-gauge, 3.5-inch whitacre needle.The 3.5-inch whitacre needle was manufactured by defendant becton dickinson and company.On (b)(6), 2019, plaintiff, (pt name redacted) was noted to be positive for methicillin susceptible staphylococcus aureus (¿mssa¿).On (b)(6), 2019, (pt name redacted) was noted to be negative for methicillin resistant staphylococcus aureus (¿mrsa¿).Early post-operatively, plaintiff (pt name redacted) developed discitis and was readmitted with bacteremia on (b)(6) 2020.On (b)(6) 2020, (pt name redacted) presented to (hospital name redacted) with high fever, significantly elevated white blood cell count of 22,000, and back pain.Blood cultures taken on (b)(6) 2019, revealed the presence of high grade, persistent bacteremia with mrsa in (pt name redacted) bloodstream.Medical providers at (hospital name redacted) noted a diagnosis of mrsa bacteremia with possible spinal epidural abscess or discitis, status post epidural for knee replacement.Plaintiff (pt name redacted) was treated for mrsa bacteremia, l4-l5 discitis, and an epidural abscess.Plaintiff¿s history of infection states that his mrsa infection date is (b)(6) of 2019.(pt name redacted) suffered damages including but not limited to, pain, suffering and disability causing the plaintiff to seek further medical treatment and incur further medical bills and the plaintiff, (pt name redacted), will in the future be caused great pain and suffering, required to seek medical treatment and incur medical bills.Plaintiff (pt name redacted) was treated for l4-l5 discitis and an epidural abscess during his (b)(6), 2019 admission to (hospital name redacted).After the (b)(6), 2019 procedure, (pt name redacted) had mrsa bacteremia in his lumbar spine.Pt name redacted) developed mrsa bacteremia from the procedure of the spinal anesthesia block via single shot injection at the l3-l4 spine performed on (b)(6) 2019.

• Brand Name: UNSPECIFIED BD WHITACRE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11286414
• MDR Text Key: 233469540
• Report Number: 2243072-2021-00232
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention