MAUDE Adverse Event Report: HOLOGIC INCORPORATED APTIMA, SWAB SPECIMEN COLLECTION KIT

Model Number	MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial: on 06/11/2021, the fda received a report (mw5101852) through the fda's medwatch program.The report was forwarded by the fda to hologic and was received on 07/16/2021.A customer submitted a mdr to the fda regarding a box of specimen collection kits, multitest swab, ivd (pn: prd-03546) which contains multitest swab specimen collection kits (pn: asy-00848 ln: 288775).The report stated that there were multiple instances where the swab bulb from aptima multitest swabs detached during collection of vaginal samples when using standard specimen collection procedures.In multiple instances the provider needed to perform a speculum exam to remove the retained material.The report did not provide dates for when these instances occurred, and did not include pictures of the impacted swabs for assessment.The report also did not indicate that there was an injury as a result of retrieving the bulbs from the patients.The package insert "aptima® multitest swab specimen collection kit" aw-14413-001 rev.010 states "gently rotate the swab for 10 to 30 seconds" for vaginal swab collection.Hologic requested the swab supplier to perform further investigation.
Additional Manufacturer Narrative
"date of event" of (b)(6) 2020 was incorrect on the initial report dated (b)(6) 2021.The correct "date of event" is (b)(6) 2021.
Event or Problem Description
Follow-up/final.On 06/11/2021, the fda received a report (mw5101852) through the fda's medwatch program.The report was forwarded by the fda to hologic and was received on 07/16/2021.A customer submitted a mdr to the fda regarding a box of specimen collection kits, multitest swab, ivd (pn: prd-03546) which contains multitest swab specimen collection kits (pn: asy-00848, ln: 288775).The report stated that there were multiple instances where the swab bulb from aptima multitest swabs detached during collection of vaginal samples when using standard specimen collection procedures.In multiple instances the provider needed to perform a speculum exam to remove the retained material.The report did not provide dates for when these instances occurred, and did not include pictures of the impacted swabs for assessment.The report also did not indicate that there was an injury as a result of retrieving the bulbs from the patients.The package insert "aptima® multitest swab specimen collection kit" aw-14413-001 rev.010 states "gently rotate the swab for 10 to 30 seconds" for vaginal swab collection.Hologic requested the swab supplier to perform further investigation.Supplier checked their batch records and retention samples for each lot reported with no anomalies found; retentions were pull-tested with no failures found.Supplier noted that they have many controls in place to reduce detaching of swab head during manufacturing.The root cause could not determine as returned samples and photographs were unavailable.Hologic also checked retention in inventory by visually inspecting and measuring using tool fixture.All swabs were found to "meet" specification.All swab "bulbs" inspected were found to be tightly wound to the swab shaft.To further clarify, the hologic instruction for use (ifu) will be updated to add verbiage to "rotate the swab clockwise".

• Brand Name: APTIMA, SWAB SPECIMEN COLLECTION KIT
• Common Device Name: APTIMA, SWAB SPECIMEN COLLECTION KIT
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• MDR Report Key: 12310921
• Report Number: 2024800-2021-00005
• Device Sequence Number: 1140200
• Product Code: JTW
• UDI-Device Identifier: 25420045510187
• UDI-Public: 25420045510187
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K032554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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
• Operator of Device: No Information
• Device Model Number: MULTITEST SWAB COLLECTION KIT,APTIMA,IVD
• Device Catalogue Number: PRD-03546
• Device Lot Number: 288775
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other