MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Material # 309620 batch # 4172751 it was reported by customer that bd 50 ml syringe with a catheter tip.Inside the cap has brown sediment.Verbatim: i wanted to bring to your attention two items found in 3 main¿s clean utility room.The first is a bd 50 ml syringe with a catheter tip.Inside the cap has brown sediment.Pictures are included below.The nurse was opening up the package, which was sealed, and found the cap to be contaminated.The second item is a luer lock syringe packed out on shelves in no packaging or in any bag.These syringes are used for feeding tubes, and packed out with no covering they are exposed to potential dust or contaminants.I have included pictures of both products as well as the packaging for the bd syringe with the lot number.Thank you,.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the cap has a brown sediment.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, four photos were provided for evaluation by our quality team.Two photos show a syringe with the tip cap that has brown colored specks.One photo shows the inner side of the tip cap confirming the specks are in the cap.From these photos, it is not clear if the specks are embedded.The fourth photo shows a packaging blister top web.No other defects or imperfections were observed.A device history record review was completed for provided material number 309620, lot 4172751.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.
Event or Problem Description
No additional information received.Material # 309620; batch # 4172751.It was reported by customer that bd 50 ml syringe with a catheter tip.Inside the cap has brown sediment.Verbatim: i wanted to bring to your attention two items found in 3 main¿s clean utility room.The first is a bd 50 ml syringe with a catheter tip.Inside the cap has brown sediment.Pictures are included below.The nurse was opening up the package, which was sealed, and found the cap to be contaminated.The second item is a luer lock syringe packed out on shelves in no packaging or in any bag.These syringes are used for feeding tubes and packed out with no covering they are exposed to potential dust or contaminants.I have included pictures of both products as well as the packaging for the bd syringe with the lot number.Thank you,.

• Brand Name: SYRINGE CATHETER TIP 50ML
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• 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: 20389256
• Report Number: 1911916-2024-00718
• Device Sequence Number: 15470460
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207(11)240620(17)290630(10)4172751
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: 4172751
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown