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

Catalog Number 306547

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

Material#: 306547 batch#: unknown.It was reported by customer that complaint details:.Per customer : "one of our apheresis nurses noticed an artifact within this product while preparing treatment for a patient yesterday.It¿s the 0.9% sodium chloride injection, 10 ml syringe, bd ref# (b)(4)posiflush item.It appears to be a plastic piece broken off inside the fluid.This causes some safety concerns for us and question if the rest of this lot is safe to use.I¿m sure it¿s a one off but it is difficult to be confident.Have there been other reports of issues with the product? shoud the rest of our stock be replaced and is it safe to use? ".Verbatim: rcc received a complaint via email.Email(s) attached.We have received a product complaint for item# 306547.See details below.Reported by: (b)(6).Phone#: (b)(6).Email: (b)(6).Complaint details:.Per customer : "one of our apheresis nurses noticed an artifact within this product while preparing treatment for a patient yesterday.It¿s the 0.9% sodium chloride injection, 10 ml syringe, bd ref# (b)(4).Posiflush item.It appears to be a plastic piece broken off inside the fluid.This causes some safety concerns for us and question if the rest of this lot is safe to use.I¿m sure it¿s a one off but it is difficult to be confident.Have there been other reports of issues with the product? shoud the rest of our stock be replaced and is it safe to use? ".You may reach out to us if you need anything.

Manufacturer Narrative

Pr (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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H3 other text : see h10 manufacture narrative.

Manufacturer Narrative

(b)(4) follow up for device evaluation it was reported there appears to be a plastic piece broken off inside the fluid.To aid in the investigation, one sample with no packaging flow wrap and two photos were provided for evaluation by our quality team.A visual inspection was performed.The sample has 1.5ml of solution and a piece of plastic 1/8" x 1/16" adhered to the syringe rubber stopper.It is a piece of syringe barrel flange.The sample returned has no barrel damage observed.The two photos provided show the sample received.No other defects or imperfections were noticed.This defect could occur if there was a jam during the filling process.A device history record review was completed for provided material number (b)(4), lot 3178291.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.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.

Event Description

No additional information received material#: (b)(4) batch#: unknown it was reported by customer that complaint details:.Per customer : "one of our apheresis nurses noticed an artifact within this product while preparing treatment for a patient yesterday.It¿s the 0.9% sodium chloride injection, 10 ml syringe, bd ref# (b)(4), posiflush item.It appears to be a plastic piece broken off inside the fluid.This causes some safety concerns for us and question if the rest of this lot is safe to use.I¿m sure it¿s a one off but it is difficult to be confident.Have there been other reports of issues with the product? should the rest of our stock be replaced and is it safe to use? ".Verbatim: rcc received a complaint via email.Email(s) attached.We have received a product complaint for item# 306547.See details below.Reported by: (b)(6) phone#: (b)(6) email: (b)(6) complaint details:.Per customer : "one of our apheresis nurses noticed an artifact within this product while preparing treatment for a patient yesterday.It¿s the 0.9% sodium chloride injection, 10 ml syringe, bd ref# (b)(4), posiflush item.It appears to be a plastic piece broken off inside the fluid.This causes some safety concerns for us and question if the rest of this lot is safe to use.I¿m sure it¿s a one off but it is difficult to be confident.Have there been other reports of issues with the product? should the rest of our stock be replaced and is it safe to use? ".You may reach out to us if you need anything.

• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18397691
• MDR Text Key: 331723753
• Report Number: 1911916-2023-00915
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024
• 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: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1