MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL TIP 1ML; SYRINGE, PISTON

Catalog Number 309653

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

Material#: 309653 batch#: 3208333.It was reported by customer that 3 broken 50ml syringes in the past year.Any adverse event or serious injury reported to patient or healthcare professional? pt pressure dropped significantly which was exacerbated by the inability to remove pressure from the balloon.2.Was there a delay of, or change in, the course of treatment due to the event? code blue called 3.Any sample or photo available for investigation? yes 4.How was the patient outcome? are there any clinical signs, health consequences or impact? patient stable now.Was intubated with cpr at the time of the event.5how was treatment completed for customer? after the patient was stabilized, procedure completed with second syringe.6.Patient status? alive 7.Syringe is broken which part is broken luer/ barrel? plunger handle.

Manufacturer Narrative

Pr 9330062: initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Device problem code: a0401 ¿ break patient problem code: e2321 - low blood pressure/ hypotension f2306 - resuscitation.

Event Description

(b)(4) no additional information received.Material#: 309653, batch#: 3208333.It was reported by customer that 3 broken 50ml syringes in the past year.Verbatim: 3 broken 50ml syringes in the past year.0on 1dec2023 , any adverse event or serious injury reported to patient or healthcare professional? pt pressure dropped significantly which was exacerbated by the inability to remove pressure from the balloon.2.Was there a delay of, or change in, the course of treatment due to the event? code blue called 3.Any sample or photo available for investigation? yes.4.How was the patient outcome? are there any clinical signs, health consequences or impact? patient stable now.Was intubated with cpr at the time of the event.5how was treatment completed for customer? after the patient was stabilized, procedure completed with second syringe.6.Patient status? alive.7.Syringe is broken which part is broken luer/ barrel? plunger handle.8.Please elaborate the details?.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there were broken 50ml syringes.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the plunger rod is damaged and broken.No other defects or imperfections were observed.This defect could occur if there is a jam during the assembly process.A device history record review was completed for provided material number 309653, lot 3208333.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.It appears this defect is occurring below its expected frequency.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 50ML LL TIP 1ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18294837
• MDR Text Key: 330832035
• Report Number: 1911916-2023-00886
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: (01)30382903096535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309653
• Device Lot Number: 3208333
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention