MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Contamination (1120)

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

Event Date 04/05/2024

Event Type  malfunction  

Event Description

Material#: unknown, batch#: 3355044 / unknown.It was reported by customer that the sodium chloride solutions was cloudy.Rcc received a complaint via email.10ml 0.9% sodium chloride posiflush lots: 33332180 and 3355044.Medical saline flush delivered from (b)(6) are cloudy.We got some from (b)(6) hospital to carry us over the weekend.We need clear sodium chloride solutions not cloudy.My wife is on picc line fighting off a full body staphylococcus infection.Patient name: (b)(6).

Manufacturer Narrative

Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.Additional batch provided: batch: 3355044, batch creation date: 2023-12-21, batch expiration date: 2026-11-30.

Manufacturer Narrative

(b)(4) follow up, it was reported the solution was cloudy.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two prefilled syringes in their packaging flow wrap.From the photo, it is not possible to observe any discoloration, variation in color, or cloudy condition.No defects or imperfections were observed.A device history record review was completed for provided material number 306546, lots 3332180 and 3355044.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be determined.

Event Description

Additional information received 1.What is the date of event? event of discovery april 5, 2024, infusion of possible contaminated saline solution prior three days from (b)(6) 2024 through early morning of (b)(6) 2024.2.Please share the material number.Ref (b)(4).3.Provided batch number 33332180 was not found in trackwise.Please share valid batch number.Sorry lot# is 3332180.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No syptoms discovered this time, but confusion and fatigue.Temperatures are within normal range, dizziness and short of breath.Material# 306546 batch# 3355044 / 3332180.It was reported by customer that the sodium chloride solutions was cloudy.Verbatim: rcc received a complaint via email.Email(s) attached 10ml 0.9% sodium chloride posiflush lots 33332180 and 3355044.Medical saline flush delivered from (b)(6) healthcare (xxx) in hayward california are cloudy.We got some from (b)(6) hospital to carry us over the weekend.We need clear sodium chloride solutions not cloudy.My wife is on picc line fighting off a full body staphylococcus infection.Patient name xxxxx.I'm husband (b)(6).

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19106067
• MDR Text Key: 340910718
• Report Number: 1911916-2024-00260
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 306546
• Device Lot Number: 3332180
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1