MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN® SPINAL TRAY

Model Number P24BK

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Five unused kits, in their original packaging identifying the reported lot number (0061476694), were received for evaluation.The bupivacaine vials in the trays were confirmed to be from supplier lot # 582453a.The vials were forwarded to the drug manufacturer ((b)(4)) for further evaluation and analysis.The bupivacaine from the retain samples of the suspect supplier drug lot (582453a) were analyzed by the bbmi analytical lab for assay for bupivacaine hydrochloride via high performance liquid chromatography (hplc).The results of the assay for bupivacaine hydrochloride testing was found to be 99.2 percent of the labeled amount of bupivacaine, meeting the united states pharmacopeia monograph for bupivacaine hydrochloride in dextrose injection monograph drug specification of not less than 93.0 percent and not more than 107.0 percent of the labeled amount of bupivacaine.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.The investigation into this reported event is ongoing.All available information has been forwarded to the drug manufacturer for further evaluation.Following the receipt of additional information and/or completion of the investigation a follow-up report will be filed.

Event Description

As reported by the user facility: event # 4: reports seven ob patients experienced blood pressure drops during the procedure.The patients were given ephedrine in order to increase the blood pressure.The blood pressure increased after the medication and remained stable.The reporter stated this started to happen when the facility began using this lot.There were no issues with this tray from another lot.The reporter feels it may be the bupivacaine; some patients were given bupivacaine only, but some were given the epinephrine that was in the tray also.Patient # 4: age (b)(6); baseline bp-190/102; decreased bp-133/68, 91/50; bp after intervention- 119/56; was patient symptomatic: yes; dose and name of medication given - ephedrine 5mg times two at 1900 and 1905; bupivicaine, epinephrine, or both given: 5.25mg bupivacaine only.

Manufacturer Narrative

The drug manufacturer indicated that the returned drug vial samples met all internal specifications.A review of the batch record documentation for the involved drug lot was performed with no issues noted.The reported complaint condition could not be confirmed as a manufacturing related issue; therefore, a definitive root cause cannot be attributed.The drug manufacturer performs and verifies in-process and batch release test results per product specifications for every batch prior to disposition.Based on the results of this investigation, a definitive conclusion could not be made regarding the cause of the reported events.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PENCAN® SPINAL TRAY
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5646437
• MDR Text Key: 45011595
• Report Number: 2523676-2016-00275
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: P24BK
• Device Catalogue Number: 333868
• Device Lot Number: 0061476694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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
• Patient Age: 32 YR