MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 309620, batch#: unknown.It was reported by customer that enteric tube was a little clogged with miralax (i could see the small ball of medication in the sump tube before it entered the nose), i filled the syringe with warm water, tried to flush, tried to aspirate/pull back a little to loosen the clot then did a bigger flush with a little more pressure, and the cath tip literally popped off.I didn't feel like i was pushing crazy hard, a little more than usual but it wasn't hulk strength by any means.It was the catheter tip syringe.The tip was stuck in the sump tube opening, but easily came out with some hemostats.With a new syringe i tried the same thing, and the clot cleared and the tube flushed normally.Rcc received a complaint via email.'enteric tube was a little clogged with miralax (i could see the small ball of medication in the sump tube before it entered the nose), i filled the syringe with warm water, tried to flush, tried to aspirate/pull back a little to loosen the clot then did a bigger flush with a little more pressure, and the cath tip literally popped off.I didn't feel like i was pushing crazy hard, a little more than usual but it wasn't hulk strength by any means.It was the catheter tip syringe.The tip was stuck in the sump tube opening, but easily came out with some hemostats.With a new syringe i tried the same thing, and the clot cleared and the tube flushed normally'.Bd number: (b)(4).
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
Additional information received.There was no harm or injury to the patient.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the catheter tip popped off.To aid in the investigation, one sample with no packaging was received for evaluation by our quality team.A visual inspection was performed, and the syringe barrel is damaged with no luer lok.There is also a crack from the bottom of the syringe to the 25ml mark of the scale marking.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.This type of severe damage does not happen during normal use.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE, IRRIGATING (NON DENTAL)
• 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: 20558771
• Report Number: 1911916-2024-00773
• Device Sequence Number: 3103266
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/14/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown