MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE; QUICKLINK LOADER

Catalog Number 1251QCSCE

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that on tuesday the 16th during the manufacture of a grain train, a grain was stuck in the cassette while it was being inserted.It was not the first grain delivered.The cassette was changed, and there was still the same problem.After 3 or 4 grains, the cassette got stuck again.On the 23rd, it was the same problem except there was only one cassette.The cassette had to be emptied by hand, and the beans had to be inserted into the quick link by hand.

Manufacturer Narrative

Upon further review of additional information, bard/bd has determined that this event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that tuesday the 16 during the manufacture of a grain train, a grain was stuck in the cassette while it was to be inserted.It was not the first grain delivered.The cassette was changed, and it was the same problem.After 3 or 4 grains, the cassette got stuck again.On 23rd, it was the same problem except that there was only one cassette.The cassette had to be emptied by hand, and insert the beans into the quick link by hand.Per additional information received on (b)(6) 2020, both procedure cases were completed and received the appropriate doses but the situation was very stressful for the complainant.

• Brand Name: I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE
• Type of Device: QUICKLINK LOADER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9708300
• MDR Text Key: 183294892
• Report Number: 1018233-2020-01047
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K043246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCSCE
• Device Lot Number: 554140SL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1