MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN TB 1 ML 28G X 1/2; SYRINGE, PISTON

Model Number	8881882812
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the actual needle disconnects from the syringe and remains in the patient.It has occurred 4 or 5 times.Per additional information received on (b)(6) 2022, no needle was left behind in the patient.The reported problem with the needle coming off the syringe was noticed prior to any patient contact.This was noticed 4 to 5 times.The part that detached is the entire hub that holds the needle and then, is inserted into the syringe.They could see that the piece that holds the needle was not flush with the end of the syringe.It was about half way into (or half way out of) the syringe.There was no medical intervention required.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review of the reported lot number indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site was provided three photographs for product analysis with this customer report.Photo 1 shows a section of a blister lidding strip identifying it with lot 15837x exp.Date 2026-04-30.Photo 2 shows an opened unit carton with blister strip packaged product identified with lot 115837x exp.Date 2026-04-30.Photo 3 shows the top panel of a unit carton identifying it as magellan 1ml tuberculin safety syringe 28 x ½ item code 8881882812.No defects can be observed in the photographs provided.Subsequently, fifty packaged magellan 1ml tuberculin 28g x ½ safety syringes was with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.No visual issues were observed.The safety sheath was removed for evaluation of the cannula and no abnormalities were observed.The lock insert and cannula was seated correctly on the syringe barrel.A cannula pull test was performed.The testing measures the amount of force used to detach the cannula from the syringe barrel.All fifty syringe samples met the specification requirements for cannula pull testing.The reported condition of the cannula detaching from the syringe cannot be confirmed from the returned samples.The reported issue could potentially occur due to low barrels on the rail causing an alarm.If this occurrence is between 1/4 to 5 seconds, the uv ovens will shut down or the low barrel alarm can cause shutters to close and the cycle continues before the oven intensity fully cures the adhesive.If the adhesive is not fully cured on the impacted syringes, gravity would create the insert slip when they are upside down on potentially occluded syringes.Complaint trends are evaluated during monthly meetings to determine if a formal corrective/preventative action (capa) is warranted.At this time, there is not enough information to initiate a capa however, the reported condition will be communicated to the appropriate quality and manufacturing personnel.

• Brand Name: MAGELLAN TB 1 ML 28G X 1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 15136110
• Report Number: 1915484-2022-01284
• Device Sequence Number: 5197467
• Product Code: FMF
• UDI-Device Identifier: 10884521005921
• UDI-Public: 10884521005921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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
• Device Model Number: 8881882812
• Device Catalogue Number: 8881882812
• Device Lot Number: 115837X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown