MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that the customer stated that the situation occurred on the third day of the patient using his diffuser."he came normally for his session with traces of skin diffusion around the pac and the needle visibly out"."his home nurse had noticed a "leak" around the needle the day before and had tried to replace it, without becoming alarmed or clamping the product.¿ adverse patient effects are unknown.A separate complaint cn-254051 was raised for a similar concern.

Manufacturer Narrative

B3: date of event, d4: catalog number, lot number, expiration date, udi number, g5: 510k and h4: device manufacture date are unknown; no information has been provided to date.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18562299
• MDR Text Key: 333456197
• Report Number: 2183161-2024-00095
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male