MAUDE Adverse Event Report: BD INSULIN SYRG MIS 0.5 / 31G; SYRINGE, PISTON

Device Problems Loose or Intermittent Connection (1371); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Pt's mother states that when she tries to inject the zomacton the "needle is very loose and then bends" when she injects her child.The caller said the child bleeds when she injects with these needles and thinks they are defective.The caller said that the pt states that these injections hurt too bad with these needles and they haven't administered a dose since (b)(6) 2019.Pt was missed 4 doses so far.

• Brand Name: INSULIN SYRG MIS 0.5 / 31G
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 8822820
• MDR Text Key: 152232243
• Report Number: MW5088340
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290328468
• UDI-Public: 08290328468
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/03/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR