MAUDE Adverse Event Report: BECTON DICKINSON BD SWAB FLOCK MINITIP FLEXIBLE; APPLICATOR, ABSORBENT TIPPED, STERILE

Catalog Number 220252

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

The customer reported while using the bd¿ swab flock minitip flexible to collect a sample the swab broke off in the patients right nostril.The patient was sent to the operating room where an endoscope was used to remove the swab.The patient experienced discomfort and consented to sedation.

Manufacturer Narrative

Investigation summary: the customer complaint is confirmed on photos only.A review of the retains and dhr did not reveal the noted defect of broken or weak swabs.A physical stressing of the retention swabs indicated that they are within specification.A review of past complaints for this product does not reveal a trend for this issue.No further action will be taken by bd as this is considered an isolated incident.

Event Description

The customer reported while using the bd¿ swab flock minitip flexible to collect a sample the swab broke off in the patients right nostril.The patient was sent to the operating room where an endoscope was used to remove the swab.The patient experienced discomfort and consented to sedation.

• Brand Name: BD SWAB FLOCK MINITIP FLEXIBLE
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10332967
• MDR Text Key: 200788917
• Report Number: 2243072-2020-01149
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 220252
• Device Lot Number: 180824252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention