MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SALINE NORMAL 3ML PLASTIC TUBE 100 EA; REAGENT, GENERAL PURPOSE

Catalog Number 215439

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using saline normal 3ml plastic tube 100 ea missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "customer states approximately 8% of the tubes have been rejected.Customer reports that tubes have no label.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 1056378; d4: medical device expiration date: 2022-08-13; h4: device manufacture date: 2021-02-25.D4: medical device lot #: 1042727; d4: medical device expiration date: 2022-07-31; h4: device manufacture date: 2021-02-11.D10: device available for eval yes.D10: returned to manufacturer on: 2022-02-03.H6: investigation summary this statement is to summarize findings regarding the complaint related to, catalog number 215439, saline normal 3ml plastic tube 100ea, batch numbers 1056378 and 1042727.Material 215439 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The media is dispensed into bottles; caps are applied manually then torqued by machine per a standard operating procedure (sop).The bottles are then labeled and terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, bottles are packaged into final shipping configurations.The batch history record review for batch 1056378 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The appearance of this batch was satisfactory per internal procedures.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 1056378 (10 tubes) were available for inspection.All 10/10 retention samples had one properly affixed label.No photos were received to assist for this batch with this investigation.Eight tubes were returned with no labels on the tube, and no product verification.This complaint can be confirmed based on the returns.Bd will continue to trend complaints for labeling.A trend has not been identified, therefore, no actions are planned at this time.The batch history record review for batch 1042727 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, packaging, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for any defect besides customer.Retention samples from batch 1042727 (10 tubes) were available for inspection.There were no labeling defects, all 10/10 retention samples had ten properly affixed legible labels.No photos for this batch were received to assist with the investigation.No returns were received for this batch to assist with the investigation.This compliant cannot be confirmed.Bd will continue to trend complaints for contamination, labeling h3 other text : see h10.

Event Description

It was reported that while using saline normal 3ml plastic tube 100 ea missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " customer states approximately 8% of the tubes have been rejected.Customer reports that tubes have no label.".

• Brand Name: SALINE NORMAL 3ML PLASTIC TUBE 100 EA
• Type of Device: REAGENT, GENERAL PURPOSE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12071705
• MDR Text Key: 265627538
• Report Number: 1119779-2021-01062
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 215439
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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