MAUDE Adverse Event Report: HOLOGIC INC. PRESERVCYT SOLUTION; PRESERVATIVE

Catalog Number 70097-001

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Chills (2191)

Event Date 07/10/2014

Event Type  Injury  

Event Description

Hologic received notification of a customer complaint (mdr # (b)(4)) in the u.S.Which alleges that a piece from the plastic security seal used on the preservcyt solution vial was found inside a patient's vagina.The patient had a routine pap smear and complained for 8 days of abdominal pain and vaginal bleeding with associated chills.The patient also reported feeling something "hard" in her vagina.The complainant believed that a piece of the security seal separated from the rest of the seal and ended up in the patient's vagina.A plastic object was examined and photographed by the complainant.Hologic had requested that the object be returned for further investigation.If the thinprep pap test was performed by the physician according to the instructions for use provided with the test, the vial should not have been in the proximity of the patient.The thinprep pap test process is to insert a collection device into the patient to collect cells from the ectocervix, the collection device is then removed and rinsed in the preservcyt solution, and the preservcyt solution vial is capped and sent to the lab for processing.It is possible that this incident may have been caused by the negligence of the doctor when conducting an internal exam during the same office visit.It is common for physicians to conduct internal examinations after performing a pap test.If their hands were not free of debris prior to conducting an internal examination they could place an object inside the patient unknowingly.It is also possible that this incident may have been caused by the patient while using off-the-shelf products at home.There are numerous products which are used by women which contain safety seals similar to the type used with the thinprep pap test preservcyt solution vial.This is a reportable event in the u.S.Since the device has contributed to a serious injury or illness of the patient.

Manufacturer Narrative

Investigation results: the customer sent the piece of plastic in question to hologic, inc.For further analysis.This analysis included macroscopic evaluation and fourier transform infrared spectroscopy (ftir).The macroscopic evaluation of the returned sample showed that the material has similar size and shape to a safety seal removed from a thinprep pap test preservcyt solution vial.Subsequent ftir analysis of the sample matched the known safety seal material used with the thinprep pap test preservcyt solution vial.The evidence indicates that the returned sample is a fragment of a thinprep vial safety seal.

• Brand Name: PRESERVCYT SOLUTION
• Type of Device: PRESERVATIVE
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 2 navigator rd.; londonderry, NH 03053 ; 5082638922
• MDR Report Key: 4411831
• MDR Text Key: 14878302
• Report Number: 1222780-2015-00004
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2015

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: Health Professional
• Device Expiration Date: 05/07/2016
• Device Catalogue Number: 70097-001
• Device Lot Number: 4127BA
• Other Device ID Number: NONE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR