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

Catalog Number 30654778

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

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Material#: 306547 batch#: 3205340.It was reported by customer that defect/ mold found in the cap.Package sealed verbatim: defect/ mold found in the cap.

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.

Event Description

No additional information received.Material#: 306547.Batch#: 3205340.It was reported by customer that defect/ mold found in the cap.Verbatim: defect/ mold found in the cap.

Manufacturer Narrative

(b)(4) follow up.It was reported there was a defect found in the cap.As a sample was not returned, a thorough sample investigation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in its packaging flow wrap.The syringe tip cap has black specks.No other information could be obtained from the photo.A device history record review was completed for provided material number 30654778, lot 3205340.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.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

• 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: 18676066
• MDR Text Key: 335013058
• Report Number: 1911916-2024-00070
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• 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: 03/05/2024
• 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: 30654778
• Device Lot Number: 3205340
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1