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

Catalog Number 306546

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/22/2024

Event Type  malfunction  

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

Material #: 306546 batch#: 3323885 it was reported by customer that the unlabeled syringes mixed in with labelled syringes.Verbatim: rcc received a complaint via email.Email(s) attached.We received several boxes of bd posiflush normal saline flush syringes (0.9% sodium chloride injection, usp), ndc 08290-3065-46 which contained unlabeled syringes mixed in with labelled syringes.

Manufacturer Narrative

(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3323885.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

No additional information received material #: 306546 , batch#: 3323885.It was reported by customer that the unlabeled syringes mixed in with labelled syringes.Verbatim: rcc received a complaint via email.Email(s) attached.We received several boxes of bd posiflush normal saline flush syringes (0.9% sodium chloride injection, usp), ndc (b)(4) which contained unlabeled syringes mixed in with labelled syringes.

• 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: 18960617
• MDR Text Key: 338376354
• Report Number: 1911916-2024-00210
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024
• 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: 306546
• Device Lot Number: 3323885
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1