MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH-SAFESCRUB 10 ML (US/CA); SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE

Catalog Number	303191
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: unknown lot#: 7ju6x1711 it was reported by the customer that the safe scrub that she saved with what appears to have rust(?) on the inside of the packaging.Verbatim: i wanted to forward this along ¿ a staff nurse had brought a safescrub that she saved with what appears to have rust(?) on the inside of the packaging.She said that to her knowledge, the safescrub was completely sealed and covered at the time she removed the top foil.I told her i¿d pass along.She is the first that has brought this up so i¿m thinking this is a one-off, but wanted to bring to your attention.Thanks!.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for additional information received by sale's rep on 28march2024: batch number confirmed.Section d2: common device name updated, pro code updated.Section d4: batch number updated.Section g4: 510k updated.
Event or Problem Description
Material number and batch confirmed by sales rep.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported the safescrub has what appears to be rust inside the packaging.To aid in the investigation, one sample with no packaging flow wrap and two photos were provided for evaluation by our quality team.The disinfecting unit has the top web removed and loose.The unit top and top web have a brown discoloration.The two photos provided show the sample received.The sample was sent to the site that manufactures the disinfecting unit for an additional investigation.The sample received at the site had traces of possible brown oxidation in the cap and foil.Per their report, this defect could occur during the sterilization of the product.A device history record review was completed for provided material number 303191, lot 2314320.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received material#: unknown lot#: 7ju6x1711 it was reported by the customer that the safe scrub that she saved with what appears to have rust(?) on the inside of the packaging.Verbatim: i wanted to forward this along ¿ a staff nurse had brought a safescrub that she saved with what appears to have rust(?) on the inside of the packaging.She said that to her knowledge, the safescrub was completely sealed and covered at the time she removed the top foil.I told her i¿d pass along.She is the first that has brought this up so i¿m thinking this is a one-off, but wanted to bring to your attention.Thanks!.

• Brand Name: BD POSIFLUSH-SAFESCRUB 10 ML (US/CA)
• Common Device Name: SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18988009
• Report Number: 1911916-2024-00218
• Device Sequence Number: 19569855
• Product Code: QTI
• UDI-Device Identifier: 50382903031912
• UDI-Public: (01)50382903031912
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K213955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 303191
• Device Lot Number: 2314320
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 03/28/2024; 05/14/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 03/28/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown