MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTERLINK¿ BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303345
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 1300449.D.4.Medical device expiration date: 30-nov-2026.H.4.Device manufacture date: 27-oct-2021.D.4.Medical device lot #: 1260085.D.4.Medical device expiration date: 30-nov-2026.H.4.Device manufacture date: 17-sep-2021.D.4.Medical device lot #: 2014695.D.4.Medical device expiration date: 31-dec-2026.H.4.Device manufacture date: 14-jan-2022.D.4.Medical device lot #: 2027209.D.4.Medical device expiration date: 31-dec-2026.H.4.Device manufacture date: 27-jan-2022.D.4.Medical device lot #: 1300450.D.4.Medical device expiration date: 30-nov-2026.H.4.Device manufacture date: 27-oct-2021.D.4.Medical device lot #: 2014990.D.4.Medical device expiration date: 30-sep-2027.H.4.Device manufacture date:14-jan-2022.
Event or Problem Description
It was reported that the bd interlink¿ blunt plastic cannula was damaged, small piece of metal fell into the vial.The following information was provided by the initial reporter: his complaint is that when you puncture the vial with the cannula a small piece of metal falls into the vial which could be aspirated into the syringe and then be injected into a patient via iv access port.I did witness the small piece of metal sitting at the bottom of the vial after use with the cannula.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-may-2023 h6: investigation summary it was reported, during use, a small piece of metal ends up in the medication vials.To aid in the investigation, five samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed.This product is made of 100% of plastic, there is no metal.It is specified to provide sterile needleless access into pre-slit septum iv systems and vials designed for needleless access only.A device history record review was completed for provided material number 303345, lot 1300449.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, based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.
Event or Problem Description
It was reported that the bd interlink¿ blunt plastic cannula was damaged, small piece of metal fell into the vial.The following information was provided by the initial reporter: his complaint is that when you puncture the vial with the cannula a small piece of metal falls into the vial which could be aspirated into the syringe and then be injected into a patient via iv access port.I did witness the small piece of metal sitting at the bottom of the vial after use with the cannula.

• Brand Name: BD INTERLINK¿ BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16849318
• Report Number: 1911916-2023-00268
• Device Sequence Number: 20549333
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: 00382903033454
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 303345
• Device Lot Number: SEE H.10
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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