MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE

Catalog Number	309620
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown.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 the bd¿ catheter tip syringe plunger was tight and difficult to move during the nasal gastric aspiration.The following information was provided by the initial reporter: syringe is too tight.Customer complaint difficulty to do nasal gastric tube aspiration.
Event or Problem Description
It was reported that the bd¿ catheter tip syringe plunger was tight and difficult to move during the nasal gastric aspiration.The following information was provided by the initial reporter: "syringe is too tight.Customer complaint difficulty to do nasal gastric tube aspiration.".
Additional Manufacturer Narrative
H6: investigation summary it was reported the syringe was too tight.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a syringe in its packaging blister.No other information could be obtained from the photo.A device history record review was completed for provided material number 309620, lot number 0062250.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the physical sample analysis a probable root cause could not be offered.
Event or Problem Description
It was reported that the bd¿ catheter tip syringe plunger was tight and difficult to move during the nasal gastric aspiration.The following information was provided by the initial reporter: "syringe is too tight.Customer complaint difficulty to do nasal gastric tube aspiration.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 21feb2023.H6.Investigation summary: it was reported the syringe was too tight.To aid in the investigation, one sample in an opened packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, per it16 and the result was within specification.The photo shows a syringe in its packaging blister.No other information could be obtained from the photo.A device history record review was completed for provided material number 309620, lot number 0062250.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.

• Brand Name: BD¿ CATHETER TIP SYRINGE
• Common Device Name: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15518732
• Report Number: 1911916-2022-00544
• Device Sequence Number: 17639949
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: (01)00382903096206
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• 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): 02/22/2023

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: 02/28/2025
• Device Catalogue Number: 309620
• Device Lot Number: 0062250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 02/22/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/02/2022; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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