MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL; SYRINGE, PISTON

Catalog Number 300865

Device Problem Failure to Deliver (2338)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Norepinephrine running in cc pump, occlusion repeatedly.I put new intravenous ports and carrier solution that drips with the drug.Until i take the syringe out and squirt out a few milliliters, then the plunger comes off the syringe, put the syringe back in and it works.The patient's blood pressure dropped from 110 systolic to 54 systolic before the defect was corrected.I injected other drugs in parallel as the blood pressure dropped.Alaris pump is the one using.Occlusion alarm when did the incident occur? during use additional information: response received - wed (b)(6)2024 - (b)(6) 1.What was medication being used in the affected syringe? norepinephrine 1ml and sodium chloride 49ml mixed 2.How long had the medication been in the syringe before using? mixed before start-up, surgery continued for 40 minutes 3.Was there any difficulty filling the syringe with medication or expressing the air prior to use? no 4.How much medication was used to fill the syringe? more than 50ml? no only 50 ml 5.What were the medications administered while the syringe was being adjusted? (i injected other drugs in parallel as the blood pressure dropped.).Were they blood pressure medications? yes, the drugs were ephedrine and phenylephrine 6.What is the status of the patient now? don't know now, but the patient was fine postoperatively.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

No additional information.

Manufacturer Narrative

No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 300865 and lot number 2306753.During manufacturing process break out force, sustaining force and silicone content tests are performed, results for lot 2306753 are within specification limits.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.

Event Description

No additional information.

Manufacturer Narrative

Follow up mdr #2 for correction.Annex f code updated from insufficient information.

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18710811
• MDR Text Key: 335466670
• Report Number: 3003152976-2024-00079
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K110771
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300865
• Device Lot Number: 2306753
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention