MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FALCON¿ POLYESTER FIBER-TIPPED APPLICATOR SWAB, 1000; DEVICE, SPECIMEN COLLECTION

Model Number	220690
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in sparks, md has been listed as puritan medical products company, llc 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.
Event or Problem Description
It was reported that while using bd falcon¿ polyester fiber-tipped applicator swab, 1000 the customer observed that the product label was missing from the packaging.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "some of the swab packages are not sealed and there is no product information on the product packaging bag.".
Additional Manufacturer Narrative
The following fields have been corrected with the following information: d.4 medical device lot #: 8773.D.4 medical device expiration date: 06/01/2026.H.4 device manufacture date: 07/23/2021.
Event or Problem Description
It was reported that while using bd falcon¿ polyester fiber-tipped applicator swab, 1000 the customer observed that the product label was missing from the packaging.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "some of the swab packages are not sealed and there is no product information on the product packaging bag.".
Event or Problem Description
It was reported that while using bd falcon¿ polyester fiber-tipped applicator swab, 1000 the customer observed that the product label was missing from the packaging.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "some of the swab packages are not sealed and there is no product information on the product packaging bag.".
Additional Manufacturer Narrative
H.6 investigation summary: this memo serves to summarize findings on recent complaint (b)(4) on product 220690 (swube single swab sterile), lot number 8773, where it was observed that the peel pouch was broken and the product information was missing.Event description: "some of the swab packages are not sealed and there is no product information on the product packaging bag.¿ complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: the review of the device history record did not indicate any discrepancies.All release testing was satisfactory and no deviations were noted.Sample analysis: an inspection of the photos does indicate the noted defects.An inspection of the retention samples was satisfactory.Evaluations results: based on the investigation, the complaint was confirmed on the photos.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.No further actions will be taken as no confirmed trend has been identified.However, bd will continue to monitor for trending.H3 other text : see h.10.

• Brand Name: BD FALCON¿ POLYESTER FIBER-TIPPED APPLICATOR SWAB, 1000
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15246304
• Report Number: 1119779-2022-01130
• Device Sequence Number: 6612722
• Product Code: LIO
• UDI-Device Identifier: 30382902206904
• UDI-Public: 30382902206904
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2022

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
• Operator of Device: Other
• Device Expiration Date: 06/01/2026
• Device Model Number: 220690
• Device Catalogue Number: 220690
• Device Lot Number: 8773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 10/17/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown