MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN NEEDLES AND SYRINGES; SYRINGE, PISTON

Device Problem Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that a nursing associate suffered a needle stick injury in association with a monoject¿ magellan¿ insulin safety syringe with permanent needle.The exact item code involved is unknown.The customer believes it is in relation to the engagement of the needle guard.Additional information received on (b)(6) 2022 stated that the asc barely touched tip of thumb on left hand with the insulin shot.It is unknown how the safety shield was activated or if an audible click was heard.The shield did not completely cover the needle tip when in the locked position.Labs drawn: (b)(6).All (b)(6) results.

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.No physical samples or photos were provided for evaluation.Without a sample, a thorough investigation cannot be performed, and the reported issue cannot be confirmed.Therefore, an exact root cause was unable to be determined.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.A lot cannot be released unless it passes specification requirements.Based on all available information, a corrective and preventive action (capa) is not necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN NEEDLES AND SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13502052
• MDR Text Key: 288493249
• Report Number: 1915484-2022-01272
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1