MAUDE Adverse Event Report: COPAN ITALIA BD ESWAB COLLECTION KIT

Catalog Number 220245

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2014

Event Type  Injury  

Event Description

Customer called to report that on (b)(6) 2014 dr.(b)(6) was collecting a throat specimen for rapid strep screen.The 3 year child reared his head back, thus causing the swab to break at the score mark and begin to go down the child's throat.The doctor was able to retrieve the swab before it was swallowed.There was no injury, death or further treatment necessary.The doctor was using the e-swab, catalog number 220245, lot k16k45.The doctor states that this is not the usual swab they use to collect throat specimens, but has been using it for the past few weeks with no issue.

Manufacturer Narrative

Bd liquid amies elution swab (eswab) collection and transport system is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory.In the laboratory, md eswab specimens are processed using standard clinical laboratory operating procedures for bacterial culture.Bd quality was unable to confirm this customer complaint.An investigation of the retention samples and the batch history review did not reproduce the noted defect of abnormal breakage of the swab.Retention samples were found to be within specification.A review of past complaints for this product does not indicate a trend for this type of issue.Bd will continue to monitor.

• Brand Name: BD ESWAB COLLECTION KIT
• Manufacturer (Section D): COPAN ITALIA; brescia 2512 5; IT 25125
• Manufacturer (Section G): COPAN ITALIA; s.p.a. via f. perotti, 10; brescia 2512 5; IT 25125
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton cir.; sparks, MD 21152 ; 4103164367
• MDR Report Key: 3940916
• MDR Text Key: 4578284
• Report Number: 1119779-2014-00012
• Device Sequence Number: 1
• Product Code: JTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 220245
• Device Lot Number: K16K45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR