MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CULTURESWAB¿ LIQUID STUART, SINGLE SWAB; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number 220099

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ cultureswab¿ liquid stuart, single swab potential mold contamination was reported by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "there is foreign material on the swab.It looks like a dust or moldy.".

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd ds headquarters in sparks, has been listed as four oaks 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.

Manufacturer Narrative

Additional information was received which updated the investigation.H.3 device return to manuf.? yes.H.3 device eval by manufacturer? yes.H.6 investigation summary: this memo serves to summarize findings on recent complaint (b)(4) on product 220099 (culture swab liquid stuart single swab), lot number 212351100, where it was observed that there was foreign matter in the packaging.Event description: " there is foreign material on the swab.It looks like a dust or moldy." 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: a review of the device history record does not indicate any manufacturing issues.Sample analysis: the photo and return provided did show the noted defect.There was a black spot on the swab tip.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the photo and return showed the noted defect.There is no systemic failure in the manufacturing process.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 on the photo and return.No further actions will be taken as no confirmed trend has been identified.Bd will continue to monitor for trending.

Event Description

It was reported that while using bd bbl¿ culture swab¿ liquid stuart, single swab potential mold contamination was reported by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "there is foreign material on the swab.It looks like a dust or moldy.".

Manufacturer Narrative

H.6.Investigation summary; 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: a review of the device history record does not indicate any manufacturing issues.Sample analysis: the photo provided did show the noted defect.There was a black spot in the packaging.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the photo showed the noted defect.There is no systemic failure in the manufacturing process.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 on the photo.No further actions will be taken as no confirmed trend has been identified.Bd will continue to monitor for trending.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ cultureswab¿ liquid stuart, single swab potential mold contamination was reported by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "there is foreign material on the swab.It looks like a dust or moldy.".

• Brand Name: BD BBL¿ CULTURESWAB¿ LIQUID STUART, SINGLE SWAB
• Type of Device: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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: 15126592
• MDR Text Key: 304596684
• Report Number: 1119779-2022-01039
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K946283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 220099
• Device Lot Number: 212351100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1