MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW STREP A 2; MOLECULAR IVD FOR ID NOW STREP A 2

Catalog Number 734-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Incoming inspection records were reviewed for the swab provided in the id now strep a 2 kit, which is manufactured by puritan medical products company, llc, pn: 25-1506 1pf.Inspection is designed to test the durability of the swab under normal use conditions in a health care facility.All inspection specifications for the sterile foam swab pn 25-1506 1pf, lot number # 5708 were met, with no comments regarding breaking shafts.Twelve (12) retain kit swabs from lot # 5708 were inspected for flimsiness and break-ability.All twelve (12) swabs were bendable but it took multiple attempts and bends to break.The current incident rate for damaged/breaking swabs for this swab lot based on the total lot count is (b)(4).Puritan medical products company, llc (manufacturer) was notified of the complaint.Puritan's response to abbott diagnostics (b)(4), inc.Stated that they: "retrieved and inspected the retention samples and they were pristine, with no visible or detectible flaw in the applicator stick that could cause premature breakage.There were no non-conformances raised during the manufacture of the lot.".

Event Description

This report represents two (2) of two (2) incidents of a throat swab breaking during sample collection.Customer reported the sterile throat swab provided in the id now strep a kit breaking off in a pediatric patient's mouth during sample collection.The customer stated that the patient was not injured or treated as a result of the incident.The collection swabs provided in the id now strep a 2 kit are manufactured by puritan medical products company, llc.(pn: 25-1506 1pf) and received at abbott diagnostics (b)(4), inc.Where they are inspected and then added to the assay kits.The customer did not report any problems with the id now strep a 2 assay; the complaint is exclusively concerning the puritan sterile collection swab provided in the assay kit.

• Brand Name: ID NOW STREP A 2
• Type of Device: MOLECULAR IVD FOR ID NOW STREP A 2
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 9207757
• MDR Text Key: 219775791
• Report Number: 1221359-2019-00067
• Device Sequence Number: 1
• Product Code: PGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

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 Operator: Health Professional
• Device Catalogue Number: 734-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/18/2019
• 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