MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Material #: 306547.Batch #: 3207548.It was reported by customer that the plunger has been stuck and unable to push the saline.Verbatim: rcc received the complaint via email.Email(s) as attached.Lot # 3207548 10ml saline prefilled syringes.The plunger has been stuck and unable to push the saline.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0509 - physical resistance / sticking (2578/1597).Patient problem code: f26 - no health consequences or impact.

Manufacturer Narrative

Pr 9021265 follow up report: it was reported the plunger was stuck and unable to push the saline.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe with no packaging flow wrap and about 4ml of solution.No other information could be obtained from the photo.A device history record review was completed for provided material number 306547, lot 3207548.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.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the physical sample analysis, a probable root cause could not be offered.

Event Description

No additional information received.Material #: 306547; batch #: 3207548.It was reported by customer that the plunger has been stuck and unable to push the saline.Verbatim: rcc received the complaint via email.Email(s) as attached.Lot # 3207548 10ml saline prefilled syringes.The plunger has been stuck and unable to push the saline.Response received 06 oct 2023: are you able to provide the date of the event in the format of dd-mm-yyyy? 09/18/2023- how was the patient outcome? are there any clinical signs, health consequences or impact? did the event involve an urgent/life threatening medical situation? no.Did the event cause permanent impairment of a body function? did the event require medical or surgical intervention? no.Did the event cause permanent damage of a body structure? no.Any sample or photo available for investigation?.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• 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: 17894827
• MDR Text Key: 326149639
• Report Number: 1911916-2023-00750
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: 3207548
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1