MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL CANNULA INTERLINK SYRINGE; PISTON SYRINGE

Model Number	303366
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the cannula interlink syringe tip broke off during use.The following information was provided by the initial reporter: "bd syringe plastic needle broke inside iv injection site of iv burothrol did not fall inside the soluset & pt able to receive his morphine iv.1)tubing pump set custom w/3 (not readable) split septum injection port csr (b)(4))cannula syringe w/top port bed csr (b)(4)".
Event or Problem Description
It was reported that the cannula interlink syringe tip broke off during use.The following information was provided by the initial reporter: "bd syringe plastic needle broke inside iv injection site of iv burothrol did not fall inside the soluset & pt able to receive his morphine iv.1)tubing pump set custom w/3 (not readable) split septum injection port csr #83869 2)cannula syringe w/top port bed csr # 21903".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/2/2020.H.6.Investigation: a device history record review was not performed as the lot is unknown.To aid in the investigation of this incident, one sample was received for evaluation by our quality team.The sample came in a plastic bag with a tubing set and a 150ml syringe and the plastic needle is loose inside the plastic bag.The sample came with a drug, and based on the complaint description, the drug is morphine.The sample was then visually inspected with a 10x magnifier lens and there is no damage or any other imperfection.There were other products that came with the sample were not inspected as they are not manufactured by this site.As no defect was observed, the cause for defect could not be offered.

• Brand Name: CANNULA INTERLINK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10865126
• Report Number: 1911916-2020-01043
• Device Sequence Number: 2465432
• Product Code: FMF
• UDI-Device Identifier: 30382903033660
• UDI-Public: 30382903033660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K920422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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 Model Number: 303366
• Device Catalogue Number: 303366
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1