MAUDE Adverse Event Report: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2861-24
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the administration of seven day continous chemotherapy, the gripper needle broke leaving the needle sticking out of the skin of the patient.An extraction was performed.The extracted product was discarded.No further complications were reported in relation to this event.
Additional Manufacturer Narrative
B5: updated with additional information.
Event or Problem Description
Additional information was received indicating that a deltec gripper plus needle from the same lot number (3922529) as the as the discarded product (post removal) would be sent for device evaluation.Additionally, a photograph of the discarded product was examined.The examination revealed that the needle was twisted.The complaint was therefore confirmed by the photographic examination.

• Brand Name: DELTEC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10803489
• Report Number: 3012307300-2020-11130
• Device Sequence Number: 16977757
• Product Code: FPA
• UDI-Device Identifier: 10610586025655
• UDI-Public: 10610586025655
• Combination Product (Y/N): N
• Initial Reporter Country: AE
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 21-2861-24
• Device Catalogue Number: 21-2861-24
• Device Lot Number: 3922529
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention