MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE

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	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ catheter tip syringe experienced foreign matter.The following information was provided by the initial reporter: bd 50 ml catheter tip syringe was found to have contaminant on the tip of it before the package was even opened.
Additional Manufacturer Narrative
(b)(4) follow up for photo evaluation.It was reported there is contaminant on the tip of the syringe.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a packaging blister top web.The other photo shows a syringe in its packaging blister.The syringe cap has dark specks.No other defects or imperfections were observed.A device history record review was completed for provided material number 309620, lot 3096960.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, but without the physical sample analysis a probable root cause could not be offered.
Event or Problem Description
(b)(4) additional information received.Material#: 309620, batch#: 3096960.It was reported by customer that bd 50 ml catheter tip syringe was found to have contaminant on the tip of it before the package was even opened.Verbatim: one of our intermountain facilities is reporting an issue/concern with an item that it is purchased from your company.Situation: issue: bd 50 ml catheter tip syringe was found to have contaminant on the tip of it before the package was even opened.Background: event date: 9/22/2023.Ih #: 93018406.Mfg #: 309620.Description: syringe 50ml cath tip 309620.Sample available : y (if sample is available and would like it sent for your evaluation, please reply all and attach a return shipping label via email).Lot #: 3096960.Assessment: was there injury? n.Name of facility : xxx.Main contact name and phone number:xxx.Frontline caregivers contact information (if applicable): account # po purchased on: (b)(4).Recommendation/request: intermountain¿s next steps: supplier¿s next steps: if you would like the product returned, please reply all with a return shipping label attached within 10 days that this email was sent (9/25/2023).If no label is received, product will be discarded.

• Brand Name: BD¿ CATHETER TIP SYRINGE
• Common Device Name: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17882496
• Report Number: 1911916-2023-00740
• Device Sequence Number: 7695325
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: Other
• Device Catalogue Number: 309620
• Device Lot Number: 3096960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown